Peer-reviewed Articles

Please use the year list below to look at past peer-reviewed articles.

2021

Craig,J.P., Muntz,A., Wang,M.T.M., Luensmann,D., Tan,J., Travé-Huarte,S., Xue,A.L., Jones,L.W., Willcox,M.D.P., Wolffsohn,J.S. Developing evidence-based guidance for the treatment of dry eye disease with artificial tear supplements: A six-month multicentre, double-masked randomised controlled trial Ocular Surface 2021;2062-69 [ Show Abstract ]

Purpose
To assess the six-month therapeutic profiles of lipid and non-lipid-based artificial tear supplements in managing dry eye disease (DED).

Methods
Ninety-nine participants fulfilling the TFOS DEWS II diagnostic criteria for DED (64% females; mean ± SD age, 44 ± 16 years) were enrolled in a prospective, multicentre, double-masked, parallel group, randomised controlled trial. Participants instilled lipid-based nanoemulsion drops or non-lipid-based aqueous drops for six months, at least four times daily. Symptomology, tear film and ocular surface characteristics were assessed at Days 0, 30, 60, 90, 120, 150 and 180.

Results
Sustained reductions in OSDI, DEQ-5, and SANDE symptom scores from baseline were observed from Day 30 onwards in both groups (all p < 0.05) and decreased superior lid wiper epitheliopathy grades from Day 60 onwards (all p ≤ 0.01). Improvements in non-invasive tear film breakup time, and sodium fluorescein and lissamine green staining scores followed from Day 120 onwards in both groups (all p < 0.05). Tear lipid layer grades increased from Day 90 onwards only with the lipid-based drops, and with significantly greater improvement in those with suboptimal lipid layer thickness at baseline (grade ≤3; p = 0.02). By Day 180, 19% of participants no longer fulfilled the diagnostic criteria for DED.

Conclusions
Over a six-month treatment period, improvements in dry eye symptomology preceded tear film and ocular surface changes with regular use of both lipid and non-lipid-based artificial tear supplements. Both formulations addressed most mild-to-moderate forms of aqueous deficient and evaporative DED, while evaporative cases benefitted preferentially from lipid-based supplementation. This represents a first step towards mapping DED therapeutic strategies according to disease subtype and severity.

Omali,N. B., Subbaraman,L. N., Heynen,M., Lada,M., Canavan,K., Fadli,Z., Ngo,W., Jones,L. Lipid deposition on contact lenses in symptomatic and asymptomatic contact lens wearers Cont Lens Anterior Eye 2021;44(1):56-61 [ Show Abstract ]

Purpose
Lipid deposition on contact lenses (CL) has traditionally been believed to reduce comfort during CL wear. The purpose of this study was to quantify lipid deposition on CL in a group of symptomatic and asymptomatic adapted CL wearers.

Methods
This was a single-masked, randomized clinical trial. Only confirmed symptomatic (comfortable lens wear time (CWT) < 8 h and a noticeable reduction in comfort over the course of the day) and asymptomatic (CWT > 10 h and minimal reduction in comfort over the course of the day) participants were recruited to participate in the study. Participants wore senofilcon A lenses in combination with a polyquaternium-based care solution (OPTI-FREE Replenish). Worn CL samples were collected on Day 14. Deposited lipid amounts from the lenses (including cholesteryl ester, cholesterol and triolein) were quantified using a liquid chromatography-mass spectrometry technique.

Results
Lipid deposition was significantly higher in CL extracts of asymptomatic wearers compared to the symptomatic wearers for all lipid types quantified, including cholesteryl ester (2.1 ± 0.6 vs 1.6 ± 0.5 log μg/lens), cholesterol (1.5 ± 0.3 vs 1.1 ± 0.3 log μg/lens) and triolein (0.3 ± 0.2 vs 0.1 ± 0.1 log μg/lens) (all p < 0.002). The amount of cholesteryl ester deposited was greatest (p = 0.0001), followed by cholesterol, then triolein, for both the asymptomatic and symptomatic groups (both p = 0.0001).

Conclusion
This study demonstrated that the asymptomatic group deposited a significantly greater amount of lipid on their CL. Although lipid levels measured are considered low to trigger any observable clinical deposition, they may influence other clinical outcomes, particularly comfort.

Phan,C. M., Qiao,H., Yee,A., Jones,L. Deposition of Fluorescently Tagged Lysozyme on Contact Lenses in a Physiological Blink Model Eye & Contact Lens 2021;47(2):127-133 [ Show Abstract ]

PURPOSE: To visualize the deposition of fluorescein isothiocyanate (FITC) lysozyme on daily disposable contact lenses (CLs) using a novel blink model.

METHODS: Three daily disposable conventional hydrogel CLs (etafilcon A, omafilcon A, and nelfilcon A) and three silicone hydrogel CLs (delefilcon A, senofilcon A, and somofilcon A) were evaluated in the study. The CLs were mounted onto a novel blink model and exposed to an artificial tear solution containing FITC lysozyme for 2 and 10 hr. The flow rate and blink speed were set to 1 μL/min and 6 blinks/min, respectively. After the incubation period, a 5-mm-diameter disc was punched out from the center of the lens and mounted on a microscope slide. The slides were imaged using the Zeiss 510 Meta confocal laser scanning microscope, which scanned the lens from the front to the back surface at 5-μm increments.

RESULTS: There was an increase in deposition of FITC lysozyme for all lens types with increasing incubation time (P<0.05), with the exception of somofilcon A, which did not show statistical significance between 2 and 10 hr (P>0.05). The conventional hydrogel CLs deposited higher amounts of FITC lysozyme than the silicone hydrogel CLs (P<0.001), with etafilcon A depositing the highest at all time points (P<0.05). Interestingly, at the 2-hr incubation time, most CLs showed a higher amount of deposition at the front surface than the back surface of the lens. In particular, etafilcon A showed preferred deposition at the front surface at all time points.

CONCLUSION: The results suggest that there is differential deposition at the front surface of the CL, which is exposed to the prelens tear film, compared with the back surface of the CL, which is exposed to the postlens tear film. Therefore, it may be beneficial to design CL materials with differing surface properties for the front and back surfaces of the CL to enhance interactions with the tear film and ocular surface.

Schulze,M., Ng,A. Y., Yang,M., Panjwani,F., Srinivasan,S., Jones,L., Senchyna,M. Bulbar redness and dry eye disease: comparison of a validated subjective grading scale and an objective automated method Optometry & Vision Science 2021;98(2):113-120 [ Show Abstract ]

SIGNIFICANCE
In this study, assessments of conjunctival redness were performed to evaluate whether patients with or without dry eye disease (DED) could be discriminated based on this measure. Our findings suggest that subjectively grading redness by quadrant, as opposed to automated en face measurements, may be more suitable for this purpose.

PURPOSE
This study aimed to quantify bulbar redness using the validated bulbar redness (VBR) grading scale and an automated objective method (Oculus Keratograph 5M; K5M) in participants with DED and non-DED controls.

METHODS
Participants with DED (Ocular Surface Disease Index score ≥20 and Oxford scale corneal staining ≥2) and controls (Ocular Surface Disease Index score ≤10 and corneal staining ≤1) attended two study visits. In part 1A of visit 1, baseline bulbar redness was graded with the VBR scale in each conjunctival quadrant of both eyes, followed by automated measurements of temporal and nasal redness with the K5M. This was immediately followed by part 1B, during which a topical vasoconstrictor was instilled into both eyes. Redness assessments were repeated 5 and 30 minutes after instillation with both instruments. Participants returned 14 days later for visit 2, where the same assessments as for visit 1A were repeated.

RESULTS
Seventy-four participants (50 DED and 24 controls) completed the study. There were statistically significant differences in redness between the DED and control groups when assessed with the VBR scale (14/16 comparisons; all, P < .05), whereas no significant differences in K5M-derived redness between the DED and non-DED groups were found at any location or time point. Both subjective and objective instruments detected statistically significant reductions in redness 5 and 30 minutes after instillation of the vasoconstrictor (all, P < .01).

CONCLUSIONS
Although both subjective and objective instruments were sensitive to detecting changes in redness induced by vasoconstriction, statistically significant differences in redness between DED and control groups were only found using the VBR scale.

Woods,J., Jones,D., Jones,L., Jones,S., Hunt,C., Chamberlain,P., McNally,J Ocular health of children wearing daily disposable contact lenses over a 6-year period Contact Lens Anterior Eye 2021;Online ahead of print [ Show Abstract ]

Purpose
To report on the ocular health and safety of children fit with soft hydrogel daily-disposable contact lenses, and followed for 6-years in a double-masked clinical trial investigating the performance of a dual-focus contact lens designed to control myopia progression.

Methods
Children aged 8−12 years, naïve to contact lens wear, were enrolled across four international sites. During years 1–3, children were randomised to either MiSight® 1 day or Proclear® 1 day (both omafilcon A, CooperVision, Inc.). The lenses were identical in material and geometry except for the front optical zone design. At the end of year-3, all those wearing Proclear 1 day were switched to MiSight 1 day, therefore all wore MiSight 1 day in years 4−6. Subjects agreed to wear the lenses at least 10-hours/day, 6-days/week. After dispensing, study visits were at 1-week, 1-month, 6-months and every 6-months until 6-years. At each visit, ocular measurements and subjective responses were recorded. Biomicroscopy used 0–4 grading scales; grade 0 represented no findings.

Results
144 children were enrolled: 69F:75M; mean age 10.1 years; mean cycloplegic spherical-equivalent refraction -2.11D; ethnicities included 34 East-Asian, 12 West-Asian, and 79 Caucasian. 92 completed the 6-years. Only three subjects discontinued due to an ocular adverse event (AE). No contact lens related AEs were classified as serious. The incidence rate of infiltrative AEs was 0.61% (6.1/1000 wearing-years; 95%CI: 0.24%–1.57%). The most common biomicroscopy findings were limbal, bulbar and tarsal hyperaemia and tarsal roughness. 99% of all biomicroscopy findings were grade-1 or lower. After 6-years of lens wear, ocular health by biomicroscopy was similar to pre-lens wear.

Conclusions
Across the 6-years, there were no contact lens related serious AEs and biomicroscopy showed no significant changes. Results suggest that children this age can successfully wear daily-disposable hydrogel contact lenses with minimal impact on ocular physiology.

Yamasaki,K., Mizuno,Y., Kitamura,Y., McCanna,D. J., Ngo,W., Jones,L. W. The efficacy of povidone-iodine, hydrogen peroxide and a chemical multipurpose contact lens care system against Pseudomonas aeruginosa on various lens case surfaces Cont Lens Anterior Eye 2021;44(1):18-23 [ Show Abstract ]

Purpose
To determine the antimicrobial efficacy of a povidone-iodine system (PVP-I; cleadew, OPHTECS Corporation, Kobe, Japan), a peroxide system (AOSEPT Plus with HydraGlyde, Alcon, Fort Worth, TX), and a chemical multipurpose system (renu fresh, Bausch & Lomb, Rochester, NY) on contact lens case surfaces that are both in contact and not in contact with the solutions during lens disinfection.

Methods
The surfaces of the inner walls, underside of the lid, and lens holder (if applicable) of the cases were inoculated with P. aeruginosa ATCC 27853. The cases were disinfected with the solutions as per their manufacturer instructions. After disinfection, the inoculated surfaces were swabbed and the amount of surviving P. aeruginosa was determined. Following this experiment, separate cases were inoculated and disinfected as before. This time the cases were agitated after recommended disinfection time and the amount of P. aeruginosa in the disinfecting solution was quantified immediately, and again after resting for 7 days. Experiments were conducted in triplicate (n = 3).

Results
Units are expressed in log CFU. All three solutions significantly reduced P. aeruginosa on direct-contact surfaces (all p < 0.039). On non-contact surfaces, the reduction of P. aeruginosa in the PVP-I system (pre-disinfection: 6.8 ± 0.5, post-disinfection: 1.0 ± 0.0; p < 0.001) was significant, but not for the hydrogen peroxide system (pre-disinfection: 6.3 ± 0.6, post: 5.5 ± 0.5; p = 0.194) and the chemical multipurpose system (pre-disinfection: 6.6 ± 0.1, post-disinfection: 5.6 ± 0.8; p = 0.336). After 7 days post-disinfection, no P. aeruginosa regrowth was observed in the PVP-I system (Day 1: 1.0 ± 0.0, Day 7: 1.0 ± 0.0; p = 1) and the chemical multipurpose system (Day 1: 4.2 ± 0.2, Day 7: 1.8 ± 0.9; p = 0.012), however regrowth was observed in the hydrogen peroxide system (Day 1: 3.4 ± 0.6, Day 7: 6.1 ± 0.4; p = 0.003).

Conclusion
The PVP-I system was more effective against P. aeruginosa on non-contact surfaces than the hydrogen peroxide system or the chemical multipurpose system and is capable of inhibiting regrowth of P. aeruginosa for at least 7 days post-disinfection.