Fadel D, Wong S, Luensmann D, Guthrie S, Seo J, Woods J, Voltz K, Vega J. The use of Scleral Lenses to Manage Dry Eye Symptoms in Habitual Soft Lens Wearers Global Specialty Lens Symposium, Las Vegas, Jan 20, 2024 [ Show Abstract ]

PURPOSE: To determine if scleral lenses (SLs) with and without Hydra-PEG coating can improve ocular comfort and reduce dryness in symptomatic soft lens wearers.

METHODS: This prospective, randomized, double masked, 1-month bilateral cross over, daily wear study recruited symptomatic soft lens wearers who presented with healthy eyes and a CLDEQ-8 score ≥12 with their habitual contact lens (hab-CL). Eligible participants were fit with SLs (Onefit MED, CooperVision, Inc.) and wore these with and without HydraPEG coating (coated (C-SL) / uncoated (U-SL)) in a randomized order for 1 month per pair. Participants completed a CLDEQ-8 and rated comfort, vision clarity, dryness and handling after each 1-month wear period using a 0-10 scale (10=best) and these data were compared between study SLs and to their hab-CL.

RESULTS: Twenty participants (16F:4M), mean age 29.3±12.4 years [18-64 years] completed the study. The mean refraction of the right eye was Sph -4.69±3.42DS [-15.25 to -0.50DS] and Cyl -0.84±0.79DC [0.00 to -2.75DC]. At 1 month, the CLDEQ-8 score improved with both study SLs in comparison to hab-CL (p0.05) and both were rated better compared to hab-CL (p0.05). At study exit, 9 of the 20 participants requested the SL details to be shared with their eye care professional because they wanted to continue wearing these SLs in future.

CONCLUSIONS: Switching symptomatic soft lens wearers into scleral lenses improved comfort and reduced dryness symptoms after 1 month of wear, with little reduction in ease of lens handling. Subjective ratings were similar with uncoated and HydraPEG coated scleral lenses, with the latter providing slightly better visual clarity.

Fadel D, Wong S, Luensmann D, Guthrie S, Woods J, Jones L, Voltz K, Vega J. Evaluation of Scleral Lenses in the Management of Dry Eye Symptoms American Academy of Optometry Meeting, Indianapolis, Nov 8, 2024 [ Show Abstract ][ PDF ]

Purpose: This study aimed to determine if scleral lenses (SLs), either with or without a covalently bonded polyethylene glycol-based lens surface treatment (Hydra-PEG) (Tangible Science), could improve ocular comfort and decrease dryness in symptomatic habitual soft contact lens (CL) wearers and non-CL wearers.

Methods: This prospective, randomized, double-masked, 1-month bilateral cross-over, daily wear study recruited soft CL wearers with a CLDEQ-8 score ≥12 and non-CL wearers with an OSDI score ≥13. Eligible participants were fit with SLs (Onefit MED, Blanchard Contact Lens, a CooperVision Company) and wore one pair with and one pair without lens coating (coated (C-SL)/uncoated (U-SL)) in a randomized order for 1 month each. Participants completed the CLDEQ-8 and rated their overall satisfaction with ocular comfort, dryness, and vision clarity after each wear period using a 0-10 scale (10=best). These data were compared between study SLs and habitual correction (hab-correction), which is habitual CL (hab-CL) or baseline (BL) for non-CL wearers.

Results: 38 completed all study visits and were included in the analysis (20 hab-CL, 18 non-CL). At 1 month, the CLDEQ-8 score improved with both study SLs in comparison to hab-CL (p0.05) and were better than hab-correction (p0.05) but higher with C-SL than hab-CL (p< 0.05) (Hab-CL: 7.3, C-SL: 8.4, U-SL: 7.7). For non-CL wearers, comfort was improved with both study SLs compared to BL (p0.05) (BL: 4.7, C-SL: 7.3, U-SL: 7.1). Overall satisfaction with vision clarity was similar with hab-correction and study SLs (p >0.05) (hab-correction: 7.9, C-SL: 8.2, U-SL: 7.8). However, it was significantly higher with C-SL compared to U-SL for CL wearers (p< 0.05) (C-SL: 8.6, U-SL: 7.7). At study completion, 45% of participants (9 hab-CL and 8 non-CL) expressed interest in future SL wear.

Conclusion: Symptomatic soft CL wearers and non-CL wearers could successfully be fit with Onefit MED SLs. Both study SLs performed well, and only minor differences were seen between study SLs, which were typically in favor of the coated SL. After 1 month, comfort and dryness satisfaction ratings were better with SLs than hab-correction, indicating that SLs are a good option to manage patients with dry eye symptoms, irrespective of whether they are hab-CL or non-CL wearers.

Fromstein S, Guthrie S, Acs M, Caffery B, Di Marco A, Pal S, Ramdass S, Thakrar V, Zeidenberg M, Jones D, Chow A. Clinical Practice Patterns for the Initial Management of Young Myopic Patients in Canada American Academy of Optometry Meeting, Indianapolis, Nov 7, 2024 [ Show Abstract ]

Purpose: To determine how optometrists in Ontario, Canada are managing myopic pediatric patients over time, and identify factors affecting prescribing decisions.

Methods: In a retrospective chart review, children aged 6-10 who had eye exams between 2017-2021 at optometry practices in Ontario were included. Children were grouped based on presenting spherical equivalent refraction (SER) as myopes (≤-0.50D) or pre-myopes (≤+0.75D). A maximum of five unique charts were selected for each age and visit year for each group, for up to 250 files per practice. Demographic information, refraction and recommended interventions (categorized as standard myopia correction with single vision (SV) glasses or contact lenses (CL); myopia control (MC) treatment with MC glasses or soft CL, ortho-keratology (ortho-K), atropine, bifocals/progressives) were recorded. The present analysis examines how myopes were managed at their initial visit. Data were analyzed using a one-way ANOVA with post-hoc pairwise t-tests with Bonferroni correction.

Results: 2920 patients (1162 myopes) were included from 15 practices across Ontario. All practices offered at least 1 form of myopia control. The majority of clinicians recommended SV glasses/CL as the initial intervention across all years studied (93.8% in 2017 to 59.0% in 2021), although the proportion diminished over time. The most prevalent MC treatments prescribed per year were ortho-K in 2017 (3.9%), MC soft CL in 2018 and 2019 (11.8% and 11.7% respectively) and MC glasses in 2020 and 2021 (12.8% and 30.1% respectively). In later years, clinicians recommended myopia control at earlier levels of myopia; compared to 2017, the mean difference in SER with 2019 was 1.40±0.41D (mean±SE) less myopia, with 2020 1.05±0.41D less myopiaand with 2021 1.08±0.39D less myopia (all p.05). The mean age at which MC glasses (8.6±0.2 years) and MC soft CLs (8.9±0.2 years) were recommended was not statistically different, and similar to the age at which SV glasses/CL were first recommended (8.8±0.1 years; all p>.05). There was no significant difference in the refractive error of patients who were recommended MC glasses (-1.92±0.13D) versus MC soft CL (-2.05±0.15D; mean difference 0.13±0.16D, p>.05). Children with high myopia (< -6D) do not appear to be offered myopia control options as initial management. The lower limit of SER for those offered myopia control was -5.50D (MC glasses) as compared to -7.75D for standard myopia correction (SV glasses/CL).

Conclusion: The prescribing behaviour of clinicians in Ontario, Canada changed from 2017-2021 to incorporate myopia control and interventions are being prescribed at earlier stages of myopia. Neither age nor refractive error seem to impact whether the modality of glasses or CL is recommended for myopia control. Children with high myopia may still benefit from myopia control and are currently underserved.

Garg P, Shokrollahi P, Phan CM, Jones L. 3D printing of PVA loaded ocular inserts for ocular drug delivery The Association for Research in Vision and Ophthalmology, Seattle, WA, May 9, 2024 [ Show Abstract ][ PDF ]

Purpose: To develop ocular inserts comprised of polyvinyl alcohol (PVA) and gelatin methacrylate (GelMA), using 3D printing technology.

Methods: Inserts were synthesized using a bioink formulation consisting of 10% (w/v) GelMA, 5% (w/v) and 7.5% (w/v) PVA, 0.6% (w/v) lithium phenyl-2,4,6-trimethylbenzoylphosphinate (LAP), and 5% (v/v) yellow dye as a light absorbing agent to improve print resolution. They had a 4mm diameter, 1mm thickness and were fabricated using a commercial masked-stereolithography (mSLA) 3D printer at 95% humidity and 37°C temperature. Morphology of the inserts was investigated by freeze-drying samples and imaging them using a scanning electron microscope (SEM). Release of PVA over 5 hours was studied by incubating at 35°C in PBS in an incubator shaker at 50rpm. The hydrogel samples were freeze dried and their equilibrium swelling was studied in PBS using gravimetric method.

Results: The PVA-loaded ocular inserts were 3D printed within 30 minutes. SEM images showed that 7.5% PVA loaded inserts had more uniform pore size distribution compared to the gels with no PVA. Approximately 37% of PVA was released within the first 2 hrs from the inserts containing PVA, and the release continued up to approximately 4 hrs before reaching a plateau. The release kinetics can be attributed primarily due to passive diffusion. The swelling curves of these hydrogels suggest that they reach equilibrium swelling within 24hr. From the slope of the swelling curve in the first hour, it can be inferred that swelling happens at a slower rate for GelMA/PVA compared to GelMA alone. This slower swelling rate helps to control the release and supports a sustained release of PVA from the combination.

Conclusions: This study showed that a GelMA-PVA based bioink can be used to 3D print ocular inserts that can release PVA for up to 4 hours. Future work will focus on designing 3D scaffolds to increase the release duration of PVA from these gels.

Ho B, Phan CM, Garg P, Shokrollahi P, Jones L. A screening platform for simultaneous evaluation of biodegradation and therapeutic release from an ocular hydrogel and its effect on human corneal epithelial cells The Association for Research in Vision and Ophthalmology, Seattle, WA, May 7, 2024 [ Show Abstract ][ PDF ]

Purpose: To integrate human corneal epithelial cells (HCECs) into a millifluidic screening platform that quantifies biodegradation and release of an entrapped therapeutic from an ocular hydrogel.

Introduction: Biodegradable hydrogels are novel drug delivery methods designed to release entrapped drugs or therapeutics as the gel degrades in situ. The primary challenge in developing biodegradable hydrogels for drug delivery lies in accurately measuring their degradation over time, while simultaneously being able to evaluate the drug release kinetics, which is typically a cumbersome procedure. To properly evaluate the biodegradation of a hydrogel, it is also essential to simulate key factors of the target tissue environment. In the context of the eye, this includes ocular temperature, tear flow, and low tear volume. Recent advances in organ-on-a-chip technologies have made it possible to emulate the human corneal environment. This will allow more accurate measurements of hydrogel degradation rates, subsequent drug or therapeutic release, and ultimately the overall effect on human corneal epithelial cells.

Methods: Gelatin Methacrylate (GelMA) ocular inserts with polyvinyl alcohol (PVA) (10% GelMA 7.5% PVA) were placed inside a custom-designed millifluidic device. Ocular inserts were degraded with up to 200 μg/mL of matrix metallipeptidase 9 (MMP9) for 24 hours at 37oC in PBS. Biodegradation of the ocular insert was quantified using a computational image analysis pipeline. The eluates containing the degradation products were collected to measure PVA released using a spectrophotometric assay, and its toxicity on human corneal epithelial cells (HCECs) was determined by alamarBlueTM assays.

Results: There was significant biodegradation of the GelMA-PVA inserts with increasing concentration of MMP9 in the millifluidic device, which was accurately quantified using a custom computational analysis. Degradation products in the eluate were collected, and there was a ~2-fold increase of PVA released in samples treated with MMP9 compared to the control. The same eluates were non-toxic to HCECs, and interestingly protected HCECs from hyperosmotic conditions mimicking dry eye disease.

Ho B, Phan CM, Jones L, Hui A, Ketelson H. Evaluating Protective Effects of Hyaluronic Acid Containing Ophthalmic Lubricants on an in Vitro Dry Eye Model American Academy of Optometry Meeting, Indianapolis, Nov 6, 2024 [ Show Abstract ]

Purpose: To evaluate the protective effects of hyaluronic acid (HA) with the actives glycerin and polyethylene glycol/propylene glycol in ophthalmic lubricants on an in vitro model for dry eyes.

Methods: Three different topical formulations ((non-HA) containing the active hydroxyethyl cellulose, Optase® Dry Eye Intense (OI) containing the active glycerin and Systane® Hydration (SH)) containing the actives polyethylene glycol/propylene glycol were tested. The OI eye drops contained a single high MW HA polymer whereas the SH formulation contained a dual polymer system of HA and hydroxypropyl guar. The in vitro cell model consisted of immortalized human corneal epithelial cells (HCECs) cultured in DMEM/F12 media with 1% FBS and 1% penicillin/streptomycin. HCECs were seeded into 96-well plates at a density of 15,000 cells/well and incubated for 16 hr at 37°C and 5% CO2. Once confluent, media was aspirated, and HCECs were treated with HA and non-HA-based formulations for 30 min and imaged every min by brightfield microscopy. The formulations were removed, and HCECs were washed with 100 µL of PBS 0-3 times to simulate removal of the formulation from the ocular surface by tear dilution. Cells were then exposed to a dry eye environment by completely removing media for 90 seconds. Morphology changes were observed by time-lapse microscopy, and HCEC viability was determined using alamarBlueTM.

Results: There was a significant reduction in cell viability to 78% (Fig 1A) for cells desiccated in the PBS control condition (p < 0.05, two-tailed T-test). Treatment with the non-HA eyedrop showed no protection of cell viability. HA-containing formulations protected HCECs from desiccation by 98-99% (Fig 1B) compared to respective controls (p < 0.05, two-tailed T-test). This protection was maintained after multiple PBS washes. Despite the SH formulation containing two polymers, the OI treatment showed similar levels of protection against desiccation. However, the OI and SH formulations resulted in different cell morphologies. Under desiccation stress, the morphology of HCECs changed from elongated to a rounded shape (Fig 1C). HCECs treated with OI remained elongated whereas cells in SH were more circular.

Conclusion: This study utilized an in vitro dry eye cell model to evaluate the effects of HA with the actives glycerin and polyethylene glycol/propylene glycol in topical ophthalmic eye drops. Formulations containing HA protected against dry eye conditions, yet those without HA did not. HA also maintained more durable protection when exposed to rinsing mechanisms. Interestingly, protection levels may differ between different formulations of HA with the various actives when based on changes in cell morphology, warranting further investigation to identify HAs with optimal properties for ocular benefits.

Jabeen A, Luensmann D, Woods J, Hill J, Jones L. Short-term effect of DOT spectacle lenses on choroidal thickness in emmetropic children The Association for Research in Vision and Ophthalmology, Seattle, WA, May 9, 2024 [ Show Abstract ][ PDF ]

Purpose: To investigate regional changes in choroidal thickness (ChT) following short-term wear of Diffusion Optics Technology™ (DOT) spectacle lenses, designed to control myopia by lowering retinal contrast.

Method: Emmetropic children (SER +1.00 to -0.75 D) aged 8 to 14 years wore plano DOT spectacle lenses without central apertures and +3.00D spectacle lenses in a two-visit, prospective, randomized, subject-masked crossover study. High-resolution OCT (Triton DRI-OCT, Topcon) evaluated central, parafoveal (3 mm from the fovea) and perifoveal (6 mm from the fovea) ChT after 0, 30 and 60 minutes of viewing a high contrast video at each visit.

Results: A total of 30 participants (17F, 13M) with a mean (± SD) age of 10.9 (1.7) years completed the study. After 30 minutes of spectacle lens wear, a significant increase in ChT was observed with DOT spectacle lenses compared to +3.00D spectacle lenses in 4 of the 9 macula regions evaluated (p<0.05 for all). DOT spectacles showed a significant ChT thickening in the central (+7.69 ± 4.19 μm), parafoveal regions at nasal (+9.01 ± 2.77 μm) and temporal (+6.20 ± 5.46 μm) and inferior perifoveal (+9.79 ± 2.31 μm) compared to myopic defocus with +3.00D lenses. After 60 minutes, ChT remained higher only in the inferior parafoveal region (+3.96 ± 8.33 μm, p=0.03), while all other regions returned to baseline levels.

Conclusion: After short-term DOT spectacle lens wear, emmetropic children experienced macula ChT thickening, similar or greater than the response observed with +3.00D spectacle lens wear. These results indicate the choroid is able to respond to contrast reduction. Further research is required to investigate the long-term impact of contrast modulation on ChT.

Jones D, Guthrie S, Acs M, Caffery B, Di Marco A, Fromstein S, Pal S, Ramdass S, Thakrar V, Zeidenberg M, Chow A. Initial Clinical Management of Myopic and Pre-Myopic Patients in Ontario, Canada – how has this changed over time? International Myopia Conference, Sanya, Hainan, China, Sep 25 , 2024 [ Show Abstract ]

Purpose: To determine how optometrists in Ontario, Canada are changing their management of myopic and pre-myopic pediatric patients at their initial visit over time

Methods: In a retrospective chart review, charts for 2920 patients aged 6-10 with presenting refraction of ≤-0.50D (myopes) or ≤ +0.75D (pre-myopes) were reviewed. All patients had eye examinations between 2017-2021 at optometry practices in Ontario. A maximum of five unique charts were selected for each age (6, 7, 8, 9, 10) and visit year (2017 to 2021) for each group (myopes, pre-myopes), for up to 250 files per practice. Demographic information, refraction and recommended interventions (categorized as standard myopia correction with single vision (SV) spectacles or contact lenses; myopia control treatment with myopia control spectacles or contact lenses, ortho-K, atropine, bifocals/progressives; and lifestyle changes (increasing outdoor time and reducing screen time)) were recorded. A two-way ANOVA with post-hoc Bonferroni-corrected t-tests were used to determine whether visit year and discussion type differed across myopic and pre-myopic groups at their initial visit.

Results: Optometrists in Ontario, predominantly recommended SV spectacles at the initial visit across the 5 years (89.56% in 2017 to 48.88% in 2021), some optometrists increased the incorporation of myopia control treatments in their discussions over time (increasing from 8.84% in 2017 to 44.84% in 2021, F2,8=31.33, p=0.0002). Patients recommended myopia control are on average 0.58D more myopic than those prescribed standard myopia correction (mean spherical equivalent  standard error for myopia control treatment -1.890.09 DS vs standard myopia correction -1.310.05 DS, F1,1147 = 62.08, p0.05). 95% of optometrists monitor pre-myopic children with no treatment. A small group of optometrists, 0.85%, prescribed bifocals/progressives as an attempt at preventative myopia control, the sole modality employed. Awareness of parental history of myopia increased the likelihood of discussing myopia control with myopic patients (2.63x more likely if one parent was myopic and 4.68x more likely if both parents were myopic). Age and gender did not appear to be factors impacting recommendations for myopia control or lifestyle changes, this was unchanged over the years.

Conclusions
While optometrists in Canada are increasingly integrating evidence-based practices in the clinical management in myopic children and children at risk of myopia, this study reveals knowledge gaps that should be the focus of continuing education programs. Recommendations include: initiating myopia control earlier instead of waiting for further progression of myopic refractive error and discussing lifestyle changes with pre-myopic children for optimal efficacy in delaying the onset of myopia.

Jones L. New materials and emerging techniques Minisymposium: Contact lens is not a piece of plastic: Back to the future. The Association for Research in Vision and Ophthalmology, Seattle, WA, May 8, 2024 [ Show Abstract ]

Recent advancement and diversification in contact lenses are remarkable. Today, contact lenses are not merely correcting tools for refractive errors, but can be used as therapeutic modalities for various diseases. With new materials and technologies entering the market, several options, such as lenses with internal wetting agents and silicone hydrogel lenses, have become available for wearers seeking relief from contact lens discomfort. Custom-made contact lenses can address irregular astigmatism and improve the vision in eyes with irregular corneas. Myopia has become increasingly prevalent worldwide over the past century. Contact lenses such as orthokeratology lenses or multifocal soft contact lenses are commonly used for myopia control. Numerous studies and clinical experience show that we can prescribe interventions that significantly slow the rate of myopia progression. Contact lenses can be used as biosensors and medication depots. Intraocular pressure monitoring is essential in the diagnosis and management of glaucoma patients. Currently, continuous ocular monitoring contact lens sensor is available in clinical use, which helps clinicians personalize glaucoma treatment according to the patient’s intraocular pressure profiles. Drug-eluting contact lenses can be used for ocular drug delivery with widespread therapeutic applications. Future development of both types of lenses are of great interest. This symposium will cover some of the hottest topics in contact lenses today. Attendees will learn about exciting new lens technologies and how these lenses can help their patients.

Jones L. TFOS Dry Eye Workshop III - Management and therapy of dry eye disease Tear Film & Ocular Surface Society Conference, Venice, Italy, Nov 1, 2024

Jones L, Schallhorn J, Ng AY, Alster Y, Bosworth C. Sign and Symptom Improvements Rates Among MGD Patients Following Treatment with AZR-MD-001 for 6 Months Tear Film & Ocular Surface Society Conference, Venice, Italy, Nov 2, 2024

Jones L, Schallhorn J, Stapleton F, Alster Y, Bosworth C. AZR-MD-001 Opens Meibomian Glands, Improves Meibum and Tear Quality Resulting in Increased Wear Time and Desired Lens Use in Patients With CLD The Association for Research in Vision and Ophthalmology, Seattle, WA, May 6, 2024 [ Show Abstract ][ PDF ]

Purpose: Contact lens discomfort (CLD) is a common problem for practitioners and wearers. Individuals with CLD experience episodic or persistent ocular discomfort symptoms related to lens wear, including visual disturbances, decreased wear time, or discontinuation overall. AZR MD 001 (AZR) is an ophthalmic keratolytic, keratostatic, and lipogenic ointment containing selenium sulfide, developed to improve signs and symptoms of MGD. This study evaluated if biweekly AZR can open meibomian glands and improve comfortable wear time, allowing patients with CLD who continue to challenge their ocular surface, tear film, and meibomian glands with contact lens use, to wear their contact lenses as desired.

Methods: Adults with CLD and evidence of meibomian gland obstruction (n=67) were randomized (1:1) to AZR 0.5% (n=34) or vehicle (n=33) applied twice weekly at bedtime for 3 months in a Phase 2, multi-center, single-masked parallel-group study (NCT05548491). Key efficacy endpoints evaluated were the change from baseline (CFB) at month 3 compared to vehicle in meibomian gland secretion score (MGS), Tear film stability (TBUT) post lens removal, and total and comfortable wear time.

Results: At month 3, AZR 0.5% significantly improved signs (MGS; TBUT) and lens wear time vs vehicle. Mean [SE] CFB in MGS was 13.8 [0.67] vs vehicle 3.8 [0.68], p<0.0001; TBUT was +3.31 s [0.70] vs vehicle 0.65 s [0.72], p<0.0001; and total comfortable wear time was +192 min [38.07] vs vehicle +2.9 min [38.01], p<0.0001. Significantly more patients, who were unable to comfortably wear contact lenses as desired at baseline, were able to wear them as long as desired by month 3 (42.5% vs vehicle 6.2%, p=0.0015). Improvements over vehicle were first seen on Day 14 in MGS (Mean [SE] CFB 3.2 [0.97] vs vehicle 0.8 [0.91], p<0.0007) and at Month 1 for comfortable wear time +41.6 minutes [24.04] vs vehicle -14.2 minutes [24.04], p=0.0111. All treatment-emergent adverse events (TEAEs) (47/47, 100%) in the 0.5% group were mild to moderate. There were no discontinuations due to a TEAE.

Conclusion: AZR MD 001 significantly improved the meibum and tear film quality, resulting in improved wear time in patients with CLD compared to vehicle starting as early as 8 doses of treatment. AZR demonstrated efficacy, safety, and tolerability, with no major adverse events observed.

McKinney M, Irving E, Jones D, Christian L. Parental Compliance in Response to Vision Screenings in Waterloo, Canada American Academy of Optometry Meeting, Indianapolis, Nov 7, 2024 [ Show Abstract ]

Purpose: Pediatric vision screenings can be offered universally or targeted to high-risk groups. Universal screening programs screen all children for a vision problem. In 2018, the province of Ontario mandated a universal vision screening program for all kindergarten children (age 4-6 years). Following the screening, all parents are informed of the result and are recommended to bring their child to an optometrist for further evaluation. This study evaluates parental compliance in seeking vision care for their child after a vision screening in the Region of Waterloo (ROW).

Methods: All parents/guardians of kindergarten children who participated in the ROW vision screening program were invited to participate in the study. Parents who consented to the study completed a survey to identify 1) if their child had seen an optometrist prior to screening, 2) the result of the vision screening (pass/refer) and 3) whether an appointment was made with an optometrist following the screening. Additional questions were asked if parents reported they did not seek or plan to seek follow-up vision care following the screening, and vision screening results were obtained by public health to confirm result accuracy.

Results: 108 parents from 66 schools responded to the survey from October 2022 to December 2023. 54% (58/108) of parents reported their child had seen an optometrist within 18 months prior to the vision screening. 61% (66/108) of respondents reported their child passed the vision screening (no visual concerns detected). Of those parents that reported a pass, 47% (31/66) incorrectly reported their child passed the screening when they had actually been referred. Finally, 44% (48/108) of parents reported they took their child to an optometrist following the vision screening. Of the 56% (60/108) of parents that did not seek eye care, reasons why included: recently had an eye exam and did not require another one (42%, 25/60), lack of time (28%, 17/60), eye exams perceived not to be important (25%, 15/60), and cost (5%, 3/60).

Conclusion: Over half (54%) of the children screened were already under the care of an optometrist prior to the screening and less than half (44%) of parents were prompted to obtain eye care, including 25% who had already had a previous examination. To improve program efficacy, a targeted vision screening program and increased public education on the difference between vision screenings and eye exams, and the importance of early vision care for children is recommended.

Moezzi A, Moghadas M, Laachiri K, Lamrani M, Woods J, Jones L, Ngo W. Dry Eye Diagnostic Efficacy of Novel Ocular Thermography Metrics American Academy of Optometry Meeting, Indianapolis, Nov 8, 2024 [ Show Abstract ]

Purpose: This pilot study aimed to investigate the efficacy of novel ocular thermography metrics for screening and diagnosis of dry eye disease (DED).

Methods: This was a prospective study that enrolled 20 DED participants that were sex- and age-matched (12 female, 8 male, 33.3 ± 14.8 years) to 20 non-DED controls (12 female, 8 male, 33.6 ± 14.6 years). Participants were non-contact lens wearers, healthy, and free of ocular disease, except for DED in the DED group. During the screening visit (V1), OSDI (Ocular Surface Disease Index) score, Dry Eye Questionnaire-5 (DEQ5) score, non-invasive tear-break-up time (NITBUT), tear meniscus height (TMH), meibomian gland dysfunction (MG) score and corneal staining were obtained from both groups. DED group was defined as: OSDI score of ≥ 13 or DEQ-5 score of ≥ 6, and ≥ 1 of DED signs in at least one eye (corneal/conjunctival/lid margin staining, NITBUT < 5, Tear film osmolarity ≥ 308 mOsm/L). The next day (V2), a 30 second thermography recording of the ocular surface was conducted using an infrared recording camera (FLIR A655sc™), during which participants maintained natural blinking and constant straight-ahead gaze. Thermal cooling rate and thermal interblink interval (IBI) were derived from the recording.

Results: Thermal IBI was significantly lower in the DED group compared to the non-DED group (Mean ± SD) (1.89 ± 0.89 vs 2.54 ± 0.88; p=0.034). Thermal cooling rate (°C/sec) for 30 second measurement was significantly faster in the DED group than in the non-DED group (-0.12 ± 0.07 vs -0.08 ± 0.04; p=0.047). For clinical measurements, significant differences were noted between groups for the OSDI score, DEQ-5 score, NITBUT, MG score, corneal staining (all p<0.001) and TMH (p=0.011). Thermal IBI significantly correlated with DEQ5 score (r=-0.37; p=0.025) and OSDI score (r=-0.37; p=0.026). Thermal cooling rate correlated with DEQ5 score (r=-0.39; p=0.022) and OSDI score (r=-0.36; p=0.036). Area under the curve of the receiver operator characteristics (ROC) function was 0.70 for thermal cooling rate and thermal IBI. Thermal cooling rate (p=0.047) and TMH (p=0.044) were found as significant predictor variables for the dependent variable ‘DEQ5 score’ (linear mixed model). Thermal IBI (p=0.037) and MG score (p<0.001) were also found as significant predictor pair for ‘DEQ5 score'.

Conclusion: Thermal IBI and thermal cooling rate over 30 seconds of natural blinking were found as significant predictors of DED, suggesting the efficacy of these novel ocular thermography-derived metrics for DED screening.

Nagaarudkumaran N, Ngo W. Impaired Autophagy Dysregulates the Immune Response of the Corneal Epithelium under Hyperosmolar Stress American Academy of Optometry Meeting, Indianapolis, Nov 6, 2024 [ Show Abstract ]

Purpose: The regulation of inflammatory responses is imperative to the health of the ocular surface. Ocular aging can disrupt this regulatory process, thereby contributing to the decline of tissue function and the progression of ocular surface disease (OSD). OSD is associated with age and its core mechanism is inflammation; however, the cellular mechanism linking aging to inflammation remains elusive. A decline in autophagic function is a hallmark of cellular aging, and thus may be used to model ocular aging in vitro. The purpose of this study was to investigate the effect of impaired autophagy on the inflammatory responses from human corneal epithelial cells (HCEC) under hyperosmotic stress.

Methods: Immortalized HCEC were treated with an autophagy inhibitor, 5 mM 3-methyladenine (3-MA) or 100 µM chloroquine (CQ), for 24 hours. Untreated HCEC served as the control. Following the treatment period, HCEC were exposed to hyperosmolar media (500 mmol/kg via sodium chloride), or isomolar media (295 mmol/kg) for 6 hours. The cell supernatants were subsequently collected for inflammatory protein quantification. The pro-inflammatory cytokines interleukin (IL)-1β, IL-6, IL-8, and tumour necrosis factor (TNF)-α, and the immunoregulatory protein thrombospondin-1 (TSP-1) were quantified using electrochemiluminescence immunoassays. This experiment was conducted in technical replicates of three and was repeated three times. Inflammatory protein expression was normalized to the respective untreated HCEC control condition under either isomolar or hyperosmolar stress.

Results: Under hyperosmolar conditions, HCEC treated with either 3-MA or CQ exhibited a significantly lower expression of IL-1β (both p < 0.01), IL-6 (both p < 0.01), and TNF- α (both p 0.05). Under isomolar conditions, HCEC treated with either 3-MA or CQ exhibited no significant difference in IL-1β, IL-6, IL-8, and TNF-α expression when compared to untreated HCEC (all p > 0.06). Similarly, under hyperosmolar conditions HCEC treated with either 3-MA or CQ exhibited a significant reduction in TSP-1 expression in comparison to the untreated HCEC (both p < 0.01). Under isomolar conditions, HCEC treated with 3-MA or CQ, was also found to exhibit a significant reduction in TSP-1 expression compared to untreated HCEC (both p < 0.01).

Conclusion: This experiment found that disrupting autophagy alters the inflammatory response and its regulation associated with hyperosmolar stress. These findings suggest that aging reduces the ability of the corneal epithelium to control its response to inflammatory stimuli, potentially revealing a link between corneal aging and OSD.

NG AY, Jones L, Woods J, Basuthkar S, Keir N. Diurnal changes in corneal dendritic cell density and morphology in symptomatic and asymptomatic contact lens wearers The Association for Research in Vision and Ophthalmology, Seattle, WA, May 6, 2024 [ Show Abstract ][ PDF ]

Purpose: To explore corneal dendritic cell (DC) density and morphology in soft contact lens (CL) wearers using in vivo confocal microscopy (IVCM) after different wear times, imaging with and without CLs in situ.

Methods: This was a prospective study involving hydrogel and silicone hydrogel CL wearers (17F, 3M; 29.5±10.5 years): 10 symptomatic (S-CL) and 10 asymptomatic (A-CL), by Young’s criterion and comfortable wear time. Eligible participants attended a baseline day (no CL wear, IVCM conducted in the morning (AM) and 8 hours later (PM), three separate CL wearing days (IVCM after 1, 4 or 8 hours [randomized] with CLs removed immediately before imaging and topical anesthesia), and a day where CLs were worn all day (IVCM after 1, 4 and 8 hours of CL wear, with CLs in situ during imaging and no anesthesia). At least five non-overlapping sequence scans were taken at the central and inferior cornea with the Heidelberg Retina Tomograph III with Rostock Cornea Module. Up to five images per location were analyzed with automated DC counting software. A linear mixed model was applied for all statistical analyses.

Results: At the central cornea, DC density was greater in the AM/1 hour compared to PM/8 hours (p<0.001), and for the A-CL group compared to the S-CL group (p=0.041). There was no effect of imaging with CLs in situ on DC density; DC density with and without CLs in situ strongly correlated across all time points at both corneal locations (r=0.694 to 0.843, all p≤0.01). For cell morphology, immature dendritic cells were the dominant cell type in both groups at both locations (S-CL ≥77%, A-CL ≥78%). Mature cells made up 8-15% of all DCs. The A-CL group had 5% more mature cells than the S-CL group at the inferior cornea only (p=0.034). At both locations, 5% more mature cells were observed on lens wearing days (central p=0.043, inferior p=0.027). Time of imaging was not a significant effect on the proportion of immature or mature cells at either location.

Conclusions: This study shows subtle differences in DC density and morphology between symptomatic and asymptomatic CL wearers and over the course of the day in different corneal regions. The clinical significance of these results requires further investigation. This study supports the imaging of DCs with CLs in situ, which could simplify monitoring these cells during CL wear.

Ngo W, Nagaarudkumaran N, Huynh C. Reducing Instillation Discomfort of a 0.09% Cyclosporine a Solution American Academy of Optometry Meeting, Indianapolis, Nov 8, 2024 [ Show Abstract ]

Purpose: To quantify the instillation discomfort associated with either cold or warm instillation of a cyclosporine A solution (0.09% CsA, Sun Pharmaceutical Industries Ltd., CA).

Methods: 40 participants with symptomatic aqueous deficient dry eye (Ocular Surface Disease Index >23, strip meniscometry< 5 mm) were enrolled. A drop of cold (4°C) 0.09% CsA was instilled in one eye, and a drop of warm (23°C) 0.09% CsA was instilled in the other eye. The order and eye receiving the cold drop was randomized. Participants were instructed to rate the discomfort of each eye (0=no discomfort, 10=maximal discomfort) prior to drop instillation, immediately post-instillation, and at each subsequent minute for 10 minutes (i.e., t=0, t=1, … t=10). Area under curve (AUC) was used to quantify cumulative discomfort (discomfort summed over time). Ocular surface staining (OSS), fluorescein tear breakup time (TBUT), and meibum quality (MG score) were obtained and correlated against difference in cumulative discomfort between cold and warm instillation. 0.09% CsA was stored at 4°C for 1 month and change in nanoparticle size (NanoSight, Malvern Instruments, UK) and pH was quantified.

Results: 40 participants (39.6 ± 18.9 years old, 82.5% female) completed the study. A majority of participants (n=24, 60%) experienced reduced cumulative discomfort with cold 0.09% CsA, while the remainder experienced minimal difference (n=10, 25%), or increased cumulative discomfort (n=6, 15%). For those with reduced discomfort (n=24), cumulative discomfort associated with cold instillation (median = 11.5 (2.2, 20.0)) was significantly lower (p< 0.01) than cumulative discomfort associated with warm instillation (median = 17.5 (11.2, 32.2)). Cold instillation was associated with a median reduction of 1 discomfort point immediately post-instillation, and at all subsequent time points (all p≤0.04, but not significant at t=10), compared to warm instillation. None of the clinical tests (OSDI, MG score, TBUT, OSS) correlated with difference in cumulative discomfort (all p≥0.38). There was no apparent change in mean nanoparticle size (Δ=-13.5 nm ± 29 nm; p=0.53) and pH (Δ=0.04 units; p=0.05) over 1 month of storage at 4°C.

Conclusion: A majority of participants found relatively reduced discomfort with cold instillation of 0.09% CsA solution, lasting up to 9 minutes post-instillation. No clinical signs were capable predictors of reduced discomfort. Nanoparticle size and pH appeared to be stable over 1 month of cold stora

Otchere H, Jones L, Gorbet M. Subjective Assessment of Hydra-PEG Coated and Uncoated Scleral Contact Lens Wear Among Dry Eye Subjects American Academy of Optometry Meeting, Indianapolis, Nov 8, 2024 [ Show Abstract ]

Purpose: To assess wearing habits and subjective ratings comparing Hydra-PEG coated and uncoated scleral lens wear among dry eye disease subjects and to determine the relationship between the measured parameters.

Methods: This was a prospective, double-masked, randomized, dispensing, cross-over clinical trial involving five visits, where 20 subjects with mild to moderate dry eye disease (DED) were enrolled. The first visit involved screening and baseline measurements where scleral contact lenses (SL) were trial fitted. The second visit involved randomization and dispensing of customized SL, where each pair of lenses were worn on a daily wear basis for four weeks. Also, an internally developed wearing habit and subjective questionnaire was provided to subjects and completed daily. The third visit (after 4 weeks) involved a follow-up of the first randomized SL, where the lenses were evaluated, and questionnaires reviewed. A wash-out period of at least 48 hours was allowed before dispensing and follow-up of the other pair of SL, using the same procedures and visit schedule.

Results: Eighteen females and two males were enrolled in the study. The mean age and standard deviation (SD) were 29.10 ±7.48 (range: 21-47). The overall OSDI and SPEED scores were 36.45 ± 17.08 and 12.50 ± 4.03 respectively. The overall mean and SD of the measured parameters comparing uncoated and coated SL were: Days/hours (26.00 ± 3.42/7.18 ±1.75 vs 26.10 ± 3.65/7.16 ± 1.61), Dryness (73.43 ± 19.55 vs 76.02 ± 21.78), Burning (82.18 ± 21.69 vs 83.60 ± 22.16), Vision (71.71 ± 22.69 vs 71.01 ± 22.61), and Comfort (74.52 ± 17.83 vs 73.01 ± 20.81). There were no significant differences among the measured parameters comparing uncoated and Hydra-PEG coated SL (all, p > 0.05). However, the results showed a significant correlation in almost all of the measured parameters (p 0.6).

Conclusion: This study represents the first attempt to characterize SL-related wearing habit and subjective ratings in healthy subjects with mild to moderate DED. Since there are no established cut-off points to compare our results, it is difficult to suggest that these scores can be used to make any clinical decisions. However, these scores provide some valuable information on subjective assessment and wearing behavior of DED subjects wearing SL. The results show that patients with mild to moderate DED can successfully wear SL, with some potential benefits over their usual form of vision correction. Our results also suggest that Hydra-PEG coating did not lead to additional improvements compared to uncoated lenses.

Schulze M, Guthrie S, Ho B, Woods J, Jones L. Do Symptomatic Contact Lens Wearers Benefit from Using Lifitegrast Tear Film & Ocular Surface Society Conference, Venice, Italy, Nov 1, 2024

Schulze M, Guthrie S, Woods J, Jones L. Does Lifitegrast Improve Symptoms of Discomfort and Dryness in Symptomatic Contact Lens Wearers American Academy of Optometry Meeting, Indianapolis, Nov 8, 2024 [ Show Abstract ][ PDF ]

Purpose: To evaluate whether symptomatic contact lens (CL) wearers achieve improvements in comfort and dryness when using lifitegrast 5.0% ophthalmic solution (Xiidra) for 12 weeks.

Methods: CL wearers who rated their CL end-of-day dryness as ≥40 on a 0-100 visual analog scale (VAS; 100 = worst) and who met Young’s criteria for contact lens related dryness symptoms were classified as symptomatic CL wearers and qualified for the study. Eligible participants were asked to use lifitegrast twice/day for 12 weeks while continuing to wear their habitual contact lenses and refraining from using any other eye drops. The performance of lifitegrast was assessed after 2, 6 and 12 weeks (2W, 6W, 12W) by comparing to baseline (BL) measures for end-of-day dryness and end-of-day discomfort VAS ratings (0-100 scale; 100 worst) and the CLDEQ-8 questionnaire. Total and comfortable wear times were collected at baseline and at all study visits.

Results: A total of 40 participants completed the study (33F; mean age 30.8 ± 12.1 years). Reusable CLs were habitually worn by 35% of participants, while 65% wore daily disposable CLs. Mean (±SD) subjective ratings of CL wear-related dryness (BL: 66 ± 25; 2W: 42 ± 26; 6W: 31 ± 26; 12W: 21 ± 22) and discomfort (BL: 61 ± 27; 2W: 41 ± 27; 6W: 30 ± 26; 12W: 20 ± 22) improved over time, with significant differences after 2, 6 and 12 weeks of lifitegrast use for both end-of-day dryness and discomfort (all p< 0.01). All participants (100%) scored at least 40/100 for CL end-of-day dryness rating at baseline (inclusion criterion), and this percentage (count) dropped to 55% (22) at 2W, 25% (10) at 6W and 17% (7) at 12 weeks of lifitegrast use. CLDEQ-8 scores at 2W (16 ± 5), 6W (13 ± 6) and 12W (11 ± 6) were all significantly lower (all p0.05), there was a significant improvement (all p< 0.01) in comfortable wear time at 2 weeks (8 ± 3 hours), 6 weeks and 12 weeks (both 9 ± 3 hours) compared to baseline (6 ± 2 hours).

Conclusion: Using lifitegrast for as little as 2 weeks resulted in significant improvements in symptoms of end-of-day of discomfort and dryness and a longer comfortable wear time. Lifitegrast may be a suitable alternative for symptomatic CL wearers who are unable to achieve satisfactory comfort and dryness with alternate CLs or over-the-counter comfort enhancing drops.

Shukla M, Jones L, Hui A.. Poly (vinyl alcohol) elution from commercial contact lenses . Controlled Release Society Annual Meeting and Expo, Bologna, Italy, Jul 10, 2024 [ Show Abstract ]

Introduction: Contact lenses (CL) are a common form of refractive error correction, with approximately 140 million contact lens wearers across the world and 40 million in the US. Unfortunately, wearing contact lenses can cause discomfort and dryness, with almost half of all wearers experiencing these type of symptoms during use. (2) (1) Polyvinyl alcohol (PVA) is a lubricant which is effective against CL discomfort when used as an eye drop.(3) The purpose of this study was to investigate PVA elution from commercial contact lenses for a one-day wear modality. This study hypothesizes that by incorporating freezing as part of PVA loading into contact lenses, hydrogen bonding of PVA to lens materials will be enhanced, enabling the formation of a surface layer on contact lenses and increased PVA elution.

Methods: Commercial contact lenses (1-Day Acuvue® Moist® (etafilcon A, Johnson and Jonson), Acuvue® Oasys (senofilcon A, Johnson and Johnson), and DAILIES® AquaComfort PLUS® (nelfilcon A, Alcon)) were soaked in 2.5% w/v high molecular weight (avg. - 166 kDa) PVA solutions at 37°C for 48 hours. This was followed by 1 hour at either room temperature or freezing at -80°C. Total PVA release from lenses was determined in a vial containing 2 mL PBS on an orbital shaker at 50 RPM for 24 h. PVA was quantified using UV at 630 nm. All experiments were performed with n=6.

Results: A significant (p0.05) change in the amount of PVA released after freezing. Etafilcon A lenses released 17.03 ± 3.03 μg and 20.21 ± 2.51 μg (p>0.05), and senofilcon A showed 20.33 ± 6.60 μg and 24.14 ± 2.58 μg (p>0.05) at room temperature and after freezing at -80°C for one hour, respectively. However, nelfilcon A did not show significant (p>0.05) effect after 5 free-thaw cycles.

Conclusions/Implications: The findings suggest that the freezing technique has potential applications in enhancing the release of PVA from nelfilcon A contact lenses, which contains PVA internally. This provides insights into optimizing contact lens design for improved comfort by utilizing PVA release. The impact of freezing on nelfilcon A lenses releasing PVA indicates a promising potential avenue for enhancing the release of other comfort agents. Learning Objective 1: Understand the impact of freezing on enhancing the release of PVA from different contact lenses

Spafford M, Jones D, Christian L, Labreche T, Furtado N, MacIver S, Irving E. Public Perspectives on Eye Educational Videos and Posters American Academy of Optometry Meeting, Indianapolis, Nov 7, 2024 [ Show Abstract ]

Purpose: Studies have shown that the public has a limited knowledge about common eye conditions, diseases, and procedures, and an inadequate awareness of asymptomatic eye disease. Low health literacy is associated with poor health outcomes that drive underutilization of eye care services. Additional eye and vision education is needed. This beta study examined public perspectives on a set of eye and vision educational materials (EVEMs).

Methods: Five videos (< 30 seconds) and seven posters were developed based on common risks to vision (e.g., glaucoma, diabetes, amblyopia, ultraviolet radiation, macular degeneration). A 14-item REDcap survey was generated to reflect the research team’s knowledge of eye care, eye health literacy, and health messaging. Likert scale items provided five choices (e.g., strongly disagree, disagree, undecided, agree, strongly agree). A convenience sample of 160 eligible Canadian residents (at least 18 years old but not eye care professionals) were surveyed. Informants reviewed either two videos or two posters. Frequency-based scores (range: -2.0 to 2.0) were analyzed for individual survey items and four item categories: 1) Message (specific eye and vision facts), 2) Appeal (i.e., positive, understandable, funny, unscary, important, entertaining), 3) Eye Exam Importance, and 4) Action (motivate, convince, share, book eye exam), using a two-tailed, one-sample t-test (null=0, α=0.05). Only video informants answered Action items. Video and poster category scores were compared (two-tailed independent t-test, α = 0.05).

Results: Forty-four surveys were returned; 35 (22% response rate) were completed and analyzed (11 video informants; 24 poster informants). Informants were 66% female, 31% male, 23.5% (20 to 40 years), 53% (41 to 65 years), and 23.5% ( >65 years). Of the 12 EVEMs, scores were significantly positive for Eye Exam Importance (11), Message (8), and Appeal (6) (t-test≥2.536, p≤0.038). Five EVEMs (glaucoma and child eye exam videos, and macular degeneration/smoking, visual impairment/rehabilitation, and nutrition posters) obtained positive scores for all three of these categories (t-test≥2.679, p≤0.032), while 1 EVEM (glaucoma poster) did not obtain any positive scores for these measures (t-test≤1.750, p≥0.178). The Message score was significantly higher for videos than posters (t-test=2.39, p=0.04). None of the videos obtained significantly positive Action scores (t-test≤0.854, p≥0.418).

Conclusion: The public educational videos and posters tested strongest for Eye Exam Importance, then Message conveyance, followed by Appeal. This feedback approach enables refinement of lower scoring media for further testing. Of concern, despite more effective message conveyance with the videos, informants were not motivated to act (i.e., share the videos or book an eye exam).

Tuan K, Dillehay S, Tse D, Tucker A, Caffery B, Isaacs S, Cooper J, Eiden SB, Woods J, Benoit D. Accommodative Accuracy of Children Wearing Catenary Curve Multifocal Lenses, 1-year PROTECT Results American Academy of Optometry Meeting, Indianapolis, Nov 7, 2024 [ Show Abstract ]

Purpose: Accommodative accuracy during near tasks may impact visual comfort and myopia progression. The impact of accommodative accuracy from wearing single-vision or catenary curve multifocal contact lenses was evaluated from the results of a randomized controlled study (PROTECT).

Methods: Myopic children between 7 to < 13-year-old were recruited in the The PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial (PROTECT). Accommodative accuracy was measured using the Monocular Estimation Method (MEM), with the 20/125 line of a ETDRS nearpoint card at 40cm. Data was collected at the Baseline (BL) over manifest refraction; children then were fitted with assigned study lenses and their accommodative accuracy were measured at 1-month (1M) and 12-month (12M) visits wearing the study lenses. Paired analyses were conducted on the active subjects at 12M.

Results: There were 38 subjects from the Single-Vision Contact Lens (SVCL) arm and 89 subjects from the NaturalVue Multifocal (NVMF) arm at 12M. At BL, both SVCL and NVMF had similar average accommodative lag (SVCL 1.07±0.75D, NVMF 1.04±0.84D). After a few weeks of lens wear, the SVCL arm’s accommodative lag remained similar to BL (1.12±0.82D, p=0.5732), and also remained similar to BL at 12M (0.99±0.71D, p=0.2862). On average, the NVMF arm had a significant reduction of accommodative lag from BL at 1M while wearing the lenses (0.63±1.02D, p< 0.001) and the significance persisted at 12M (0.76 ± 0.67D, p0.50D at the 12M visit were the ones who had a large magnitude of lag at BL (+2.00D or more). Three subjects from the NVMF arm increased more than 0.50 D in accommodative lag at 12M compared to their BL values; all three had accommodative lead (-0.50 to -2.50D) at BL, and their accommodative lag measurements were between +0.50 to +0.75D at 12M. There were no subjects from the SVCL arm with negative values at BL and the subjects with large changes did not have a particular pattern. There was also no correlation between accommodative accuracy at BL/12M and the magnitude of axial elongation or myopia progression at 12M (R2=0.03 to 0.10).

Conclusion: The large magnitude of relative plus from NVMF did not negatively affect the subjects’ accommodation performance. NVMF’s relative plus may have reduced the accommodative stress for some subjects; in some cases, wearing NVMF appeared to have improved their accuracy to within the typical population range of accommodative lag. Nonetheless, the accommodative accuracy does not appear to be associated with myopia progression or axial elongation in this study population.

Tuan K, Dillehay S, Tse D, Tucker A, Caffery B, Isaacs S, Cooper J, Eiden SB, Woods J, Benoit D. Patient Reported Outcomes in a Randomized Controlled Myopia Progression Study (PROTECT) of a Soft Multifocal Contact Lens

American Academy of Optometry Meeting, Indianapolis, Nov 8, 2024 [ Show Abstract ]

Purpose: Multifocal optics can impact vision and comfort, which may then affect compliance with myopia control treatment in children using multifocal contact lenses. This analysis looked at the impact of optical designs to patient-reported outcomes from single-vision contact lens (SVCL) wearers and a multifocal (up to 8D add) contact lens (NVMF) wearers.

Methods: The PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial (PROTECT), recruited myopic children age 7 to < 13. The Pediatric Refractive Error Profile 2 (PREP2) was administered by the subjects along with a wearing time survey. PREP2 is a validated questionnaire for comparing vision-specific quality of life measurements between children wearing multifocal and single vision contact lenses for Myopia Progression Control, and was previously validated for this purpose in the BLINK study [doi.org/10.1111/opo.13216] evaluating myopia progression control in a single-vision contact lens versus the Biofinity Multifocal.

Results: At the 12-month visit, the NVMF group (n=93) had similar PREP2 Vision subscale scores compared to the SVCL group (n=41) and similar Symptoms (Comfort) Subscale scores. In addition, Subscales regarding the ability to carry out daily activities and lens overall performance were both similar between the two groups. The mean wearing time for the SVCL was 81.3±12.6 hrs/wk and 80.9±11.4 hrs/wk for the NVMF group with no statistical difference between groups (P=0.84).

Conclusion: In the BLINK study, the PREP2 questionnaire was able to differentiate the magnitude of impact between the groups wearing +1.50D and +2.50D add. The average score of the +2.50 group had a 3.2 points reduction in Vision Subscale compared to the +1.50D group and 4 points reduction in Vision score compared to the SVCL group. Compared with the BLINK data, the PROTECT data was within a similar range of variability on the Subscale scores. No reduction in scores were observed from the NVMF group as compared to the SVCL group for any Subscore, indicating NVMF’s multifocal optics did not cause negative impacts on the vision, comfort and vision-related quality of life measurements compared to children wearing single vision contact lenses. The average wearing time for the NVMF group was around 11-12 hours per day, and it was similar to the SVCL group, with the similar wearing times aligning with the similar PREP2 scores reported by each group . NVMF’s multifocal optics did not adversely impact the wearers’ vision-related quality of life and their daily activities, which enabled them to achieve sufficient wearing time. The potential impact of vision-related quality of life attributes with multifocal optics is an important consideration that may contribute to wearing time compliance, and should be considered when evaluating a myopia management treatment option.

Vega J, Woods J, Guthrie S, Luensmann D, Orsborn G. Ease of Success Refitting Habitual Multifocal Soft Lens Wearers with a New Progressive Multifocal Lens System American Academy of Optometry Meeting, Indianapolis, Nov 8, 2024 [ Show Abstract ]

Purpose: It is important for eye care professionals to have confidence when switching multifocal (MF) contact lens (CL) wearers to a new lens, knowing the results will be predictable and not involve excessive chair time, whether updating a prescription, selecting a different lens material or replacement frequency, or moving to a new optical system. A 2-add (High & Low) MFCL is being changed to a 3-add (High, Medium & Low) lens with a different binocular progressive system. This study was to evaluate the ease and predictability of fit and success when switching existing 2-Add wearers to the 3-Add system.

Methods: 5 US sites recruited presbyopic habitual MF wearers for a bilateral, daily wear, crossover (fixed order), subject-masked study. Subjects were fit and dispensed with clariti 1 day multifocal 2-add (somofilcon A, CooperVision, Inc.) with power optimizations after 3-7 days; optimal powers were worn for 2-weeks. Then subjects were fit with clariti 1 day multifocal 3-add and worn with the same visit schedule. LogMAR visual acuity and subjective ratings (0–10 scale;10=best) were collected after each lens wear period; preference ratings were recorded on study exit (5-point Likert).

Results: Fifty-eight participants (mean age 53.5±6.2 years, 46F:12M) completed the study. Mean refraction -1.11±2.44DS [-4.75 to +3.50], -0.27±0.25DC [0.00 to -0.75] and near addition +2.05±0.36D [+1.25 to +2.50]. There were no differences between lenses for comfort (p=0.76), vision quality (p=0.78) or overall satisfaction (p=0.94). The only statistical difference among preferences related to vision clarity for near tasks, where the 3-Add system was preferred (p=0.03). After 2-weeks, LogMAR acuity was significantly better with the 3-Add system for distance (p< 0.01) and near (p=0.02), but not for intermediate (p=0.10). When strictly following the fitting guides, the 3-Add was significantly more successful with the first pair of lenses compared to the 2-Add (80% vs 59% respectively, p=0.03); 98% of both MFCLs were successful after 1 refinement, and 100% with two.

Conclusion: The 3-Add MFCL performance matched or exceeded that of the 2-Add lens for visual acuity, subjective ratings and preference, and had a higher success rate with the first lens pair. The fit success rate for first lens pair aligns with that with MyDay multifocal (stenfilcon A, CooperVision, Inc.) that uses the same 3-Add Binocular Progressive System. This clinical study indicates that switching 2-Add wearers to the 3-Add system was generally successful, and the 3-Add lens was well accepted.

Wang T, Jones L, Semp D, Trave-Huarte S, Wolffsohn J and TFOS Ambassadors. Clinical Practice Patterns in The Diagnosis of Dry Eye Disease: A TFOS International Longitudinal Survey Tear Film & Ocular Surface Society Conference, Venice, Italy, Nov 1, 2024

Wong S, Fadel D, Seo J, Luensmann D, Guthrie S, Woods J, Voltz K, Vega J. Dry eye management with scleral lenses in non-lens wearers NCC, Veldhoven, Netherlands, Mar 10, 2024 [ Show Abstract ]

PURPOSE: To assess the benefits of scleral lenses (SLs) with and without Hydra-PEG in non-lens wearers with dry eye symptoms.

METHODS: This prospective, randomised, double-masked, 1-month bilateral cross-over study recruited symptomatic non-wearers with healthy eyes and an OSDI score ≥13. Participants were fitted with SLs (hexafocon A, Onefit MED, CooperVision, Inc.) with and without Hydra-PEG coating (Tangible Science) (coated (C-SL)/uncoated (U-SL)) for 1-month daily wear per pair. LogMAR visual acuity was measured, and participants rated overall satisfaction with ocular comfort, dryness and vision clarity using a 0-10 scale (10=best) at baseline (BL) and after each 1-month wear period with the two SLs.

RESULTS: In total, 22 participants were eligible and 18 completed the study (18F:0M, mean age 34.9±13.4 years [20-66], OSDI score 39.8±18.0 [14-80], reason for discontinuation: n=3 handling, n=1 comfort). Mean refraction of the right eye was -3.28±1.13DS [-12.00 to +1.00] and -1.11±0.90DC [0.00 to -3.25]. At 1-month, satisfaction with ocular comfort and dryness was similar between study SLs (p>0.05), and both were rated better than BL (p0.05) (BL: 7.6±19, C-SL: 7.8±2.3, U-SL: 7.8±2.9), which was confirmed by LogMAR visual acuity with no clinically relevant differences noted (BL: -0.14±0.07, C-SL: -0.17±0.07, U-SL: -0.18±0.08). At study exit, 44% asked to share their SL details with their eye care professional to continue wear in the future.

CONCLUSIONS: Symptomatic non-lens wearers were successfully fit with SLs, which improved ocular comfort and reduced dryness after 1 month of wear. Although no difference was noted between Hydra-PEG-coated and uncoated lenses, participants with a wide range of dryness symptoms benefited from SL wear and almost every second participant indicated an interested to continue SL wear.

Woods J, Guthrie S, Luensmann D, Vega J, Orsborn G. Evaluating the Success of Habitual Multifocal Soft Lens Wearers when Refit with a Progressive Multifocal Lens System NCC, Veldhoven, Netherlands, Mar 11, 2024 [ Show Abstract ]

PURPOSE: To evaluate the ease and predictability of fit and success when switching habitual, multifocal (MF) wearers from a somofilcon A (som-A) multifocal 2-Add system to a som-A 3-Add system.

METHODS: Presbyopic habitual MF wearers were recruited to a crossover, daily wear, subject-masked study. At first, participants were fit and dispensed bilaterally with som-A 2-Add (CooperVision) lenses and power optimizations were permitted at the fitting visit and the 1-week visit. The optimal lens powers were worn for 2-weeks. Next, som-A 3-Add (CooperVision) was fit and worn following the same visit schedule. Visual acuity and subjective ratings (0–10 scale;10=best) were collected after each lens wear period and preference ratings were completed at study exit (5-point Likert).

RESULTS: Fifty-eight participants (mean age 53.5±6.2 years, 46F:12M) completed the study. Mean refraction OD: Sph -1.11±2.44D [-4.75D to +3.50D], Cyl -0.27±0.25D [-0.75D to 0.00D], near addition +2.05±0.36D [+1.25D to +2.50D]. There was no difference between lenses for satisfaction with comfort (p=0.76), vision quality (p=0.78), or overall satisfaction (p=0.94). The only statistical difference among preferences related to vision clarity for near tasks, where som-A 3-Add was preferred (p=0.03). After 2-weeks, LogMAR acuity was significantly better with som-A 3-Add for distance vision (p<0.01) and near vision (p=0.02), but not different for intermediate vision (p=0.10). When strictly following the fitting guides, som-A 2-Add was successful with the first pair of lenses in 59% of participants, whereas som-A 3-Add was successful with the first pair in 80% of participants (p=0.03).

CONCLUSIONS: The performance of som-A 3-Add either matched or exceeded that of som-A 2-Add based on visual acuity, participant ratings and participant preferences. The 3-Add lens system had a higher rate of success with the first lens pair than the 2-Add system. Results indicate that switching som-A 2-Add wearers to the updated som-A 3-Add lens system was successful and well accepted.

Woods J, Richards J, Guthrie S, Kollbaum P. Can Optical Modelling Predict Clinical Vision Outcomes of Myopia Control Contact Lenses? NCC, Veldhoven, Netherlands, Mar 11, 2024 [ Show Abstract ]

PURPOSE: To understand if optical metrology and computational modelling can predict the clinical visual performance of two myopia control contact lenses which employ different optical designs: non-coaxial senofilcon A (NC) (Acuvue Abiliti 1-Day, Johnson & Johnson Vision) and dual-focus omafilcon A (DF) (MiSight 1 day, CooperVision).

METHODS: For clinical assessments, children aged 8-15 years with no history of contact lens wear or recent myopia control intervention completed a randomised, non-dispensing, contralateral double-masked trial. After 1-hour of wear, participants rated their lens preference (Likert) and subjective vision (0-100 scale, 100=best), then distance visual acuity (VA) was measured.
For optical metrology and modeling, wavefront errors were measured with an aberrometer (Optocraft GmbH). Custom software was used to compute point spread functions, image quality and simulated retinal images for 3-6mm pupils by combining the lens optics with the optics of a model young eye, assuming centred and decentred lens positions.

RESULTS: Twenty-six participants completed the clinical study: 17M; mean age 11.6yrs [8-15yrs]; mean OD refraction: -1.96DS [-0.25 to -3.50DS], -0.34DC [0.00 to -1.00DC]. Ratings of distance vision at 1-hour were better with DF (88±14) versus NC (79±18), p<0.01. Distance logMAR VA was better with DF (0.02±0.04) versus NC (0.09±0.08), p<0.01. A higher number of participants indicated overall preference for DF, with vision the most common reason (DF:14 vs NC:6, p=0.17).
Optical modelling of well-centred lenses showed reduction in image quality for both lenses as the pupil increased. Lens decentration degraded image quality for both designs, but more for the NC design. Differences in add power zone geometry and NC optics may account for these differences.

CONCLUSIONS: Both optical modelling and clinical subjective results support better image quality with the dual-focus design. These results suggest that optical modelling techniques may be valuable in evaluating and comparing myopia control lens designs prior to on-eye testing.