Peer-reviewed Articles

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

2019

Fonn,D., Jones,L. Hand hygiene is linked to microbial keratitis and corneal inflammatory events Cont Lens Anterior Eye 2019;42(2):132-135 [ Show Abstract ]

Lack of or inadequate hand washing is a risk factor in the development of contact lens related microbial keratitis and corneal inflammatory events. In the public health domain there is compelling evidence that proper hand washing with soap can save lives. The purpose of this review is to draw attention to some of the public health literature in support of hand washing and how education can influence patients’ hand hygiene behavior. Contact lens wearers are also guilty of poor hand washing behavior but there is scant evidence that education of hand washing procedures of lens wearers alters patient non-compliance. It is well known that pathogenic microbial contamination of contact lenses, lens cases, care solutions and anterior ocular components have been found with contact lens wear. However while the originating source may be hands or water, it is most likely both of these. Besides proper hand washing this paper will include mitigating strategies for avoiding microbial contamination.

Holland,E.J., Darvish,M., Nichols,K.K., Jones,L., Karpecki,P.M. Efficacy of topical ophthalmic drugs in the treatment of dry eye disease: A systematic literature review Ocul Surf 2019;Epub ahead of print [ Show Abstract ]

Dry eye disease (DED) is a multifactorial and complex disease of the ocular surface, with a high prevalence in adults. We systematically reviewed efficacy and safety data from published articles reporting results from prospective, controlled trials of topical ophthalmic drugs for DED. PubMed was searched from January 1997 to October 2017. Twenty-six unique trials investigating 13 ophthalmic drugs were identified, including trials of the approved drugs cyclosporine A, cyclosporine A cationic emulsion, diquafosol, rebamipide and lifitegrast. All identified studies provided level 1 evidence. None of the large (N > 100) studies demonstrated statistical significance of primary endpoints for both a sign and a symptom endpoint versus a control treatment in the same published trial. Publications on lifitegrast reported statistical superiority in a symptom or sign endpoint versus the control group in a large (N > 200), multicenter trial, with results repeated in trials of similar design. The most common adverse events associated with the approved drugs related to ocular discomfort upon instillation, especially burning/stinging and ocular irritation. The trial design and endpoints used across the studies varied considerably, highlighting the importance of standardization in clinical trials for DED. Recent advances in drug delivery and improved understanding of DED should contribute to new ophthalmic drug approvals.

Jones,L., Drobe,B., González-Méijome,J. M., Gray,L., Kratzer,T., Newman,S., Nichols,J. J., Ohlendorf,A., Ramdass,S., Santodomingo-Rubido,J., Schmid,K. L., Tan,D., Tan,K. O., Vera-Diaz,F. A., Wong,Y. L., Gifford,K. L., Resnikoff,S. IMI - Industry Guidelines and Ethical Considerations for Myopia Control Report 2019;60(3):M161-M183 [ Show Abstract ]

PURPOSE:
To discuss guidelines and ethical considerations associated with the development and prescription of treatments intended for myopia control (MC).

METHODS:
Critical review of published papers and guidance documents was undertaken, with a view to carefully considering the ethical standards associated with the investigation, development, registration, marketing, prescription, and use of MC treatments.

RESULTS:
The roles and responsibilities of regulatory bodies, manufacturers, academics, eye care practitioners, and patients in the use of MC treatments are explored. Particular attention is given to the ethical considerations for deciding whether to implement a MC strategy and how to implement this within a clinical trial or practice setting. Finally, the responsibilities in marketing, support, and education required to transfer required knowledge and skills to eye care practitioners and academics are discussed.

CONCLUSIONS:
Undertaking MC treatment in minors creates an ethical challenge for a wide variety of stakeholders. Regulatory bodies, manufacturers, academics, and clinicians all share an ethical responsibility to ensure that the products used for MC are safe and efficacious and that patients understand the benefits and potential risks of such products. This International Myopia Institute report highlights these ethical challenges and provides stakeholders with recommendations and guidelines in the development, financial support, prescribing, and advertising of such treatments.

Korogiannaki,M., Jones,L. W., Sheardown,H. The impact of a hyaluronic acid-grafted layer on the surface properties of model silicone hydrogel contact lenses Langmuir 2019;35(4):950-961 [ Show Abstract ]

The introduction of high oxygen transmissibility silicone hydrogel lenses ameliorated hypoxia-related complications, making them the most prescribed type of contact lens. Despite the progress made over the last two decades to improve their clinical performance, symptoms of ocular dryness and discomfort and a variety of adverse clinical events are still reported. Consequently, the rate of contact lens wear discontinuation has not been appreciably diminished by their introduction. Aiming to improve the interfacial interactions of silicone hydrogel contact lenses with the ocular surface, a biomimetic layer of the hydrophilic glycosaminoglycan hyaluronic acid (HA) (100 kDa), was covalently attached to the surface of model poly(2-hydroxyethyl methacrylate-co-3-methacryloxypropyl-tris-(trimethylsiloxy)silane) (pHEMA-co-TRIS) silicone hydrogel materials via UV-induced thiol-ene "click" chemistry. The surface structural changes after each modification step were studied by FTIR-ATR and XPS. Successful grafting of a homogenous HA layer to the surface of the model silicone hydrogels was confirmed by the consistent appearance of N (1s) and the significant decrease of the Si (2p) peaks, as determined by the low-resolution angle-resolved XPS. The HA-grafted surfaces demonstrated reduced contact angles, dehydration rate and nonspecific deposition of lysozyme and albumin, while maintaining their optical transparency (>90%). In vitro studies demonstrated that the HA-grafted pHEMA-co-TRIS materials did not show any toxicity to human corneal epithelial cells. These results suggest that surface immobilization of HA via thiol-ene "click" chemistry can be used as a promising surface treatment for silicone hydrogel contact lenses.

Moezzi,A. M., Varikooty,J., Luensmann,D., Schulze,M., Ng,A. Y., Karkkainen,T., Xu, J., Jones,L. The short-term physiological impact of switching reusable silicone hydrogel wearers into a hydrogel daily disposable multifocal 2019;13:1193-1202 [ Show Abstract ]

Purpose: To evaluate ocular physiological responses to etafilcon A multifocal (etMF) daily disposable (DD) lenses after 4 weeks of wear, when switching from habitual silicone hydrogel (SiHy) daily wear.
Method: A single-arm, open-label, bilateral dispensing study was conducted in 39 habitual spherical SiHy wearers (14 hyperopes; 25 myopes). Clinical visits occurred with habitual SiHy (control) at baseline and after 4 weeks of etMF DD open-eye lens wear at exit. Objective limbal/bulbar hyperemia using the Oculus K5M (0–4) and subjective grading of lid wiper epitheliopathy (LWE) (0–4) were tested for non-inferiority (NI), using a margin of 1 grade. Corneal thickness along a 10 mm cord was measured using the Visante OCT and tested for NI using a 30 μm margin. Corneal staining area was graded (0–100%).
Results: The least-square mean differences (LSMD) and 95% confidence interval (95% CI) between etMF DD and habitual SiHy in central and peripheral corneal thickness (μm) were 3.64 (−2.0, 9.29) and 3.0 (−7.72, 13.72) in hyperopic, and 3.56 (−0.66, 7.78) and 6.40 (−1.62, 14.42) in myopic subjects. The LSMD (95% CI) for bulbar and limbal hyperemia were −0.08 (−0.19, 0.02) and −0.01 (−0.12, 0.09) in hyperopes, and 0.04 (−0.03, 0.12) and 0.04 (−0.04, 0.11) in myopes. The LSMD (95% CI) for LWE were 0.11 (−0.39, 0.60) and 0.30 (−0.07, 0.67) for hyperopes and myopes, respectively.
Conclusions: No clinically significant differences in a variety of physiological responses were found when habitual reusable SiHy daily wear subjects were refitted into hydrogel etMF, when the subjects were followed for 4 weeks.

Ngo,W., Srinivasan,S., Jones,L. An Eyelid Warming Device for the Management of Meibomian Gland Dysfunction J Optom 2019;12(2):120-130 [ Show Abstract ]

PURPOSE: To determine the effectiveness of the MGDRx EyeBag in managing meibomian gland dysfunction.

METHODS: This was a prospective, randomized, controlled, observer-masked, bilateral eye study that enrolled 29 participants. Participants were randomized into either the EyeBag group or the control group. The EyeBag group used the EyeBag 10minutes 2x/day, and the control group remained on their own dry eye treatment regimen (if applicable). All participants were observed at baseline, 2 weeks (2wk) and 4 weeks (4wk). At 4wk, participants in the EyeBag group were asked to stop using the EyeBag. All participants were seen again at 8 weeks (8wk). Primary outcomes were the Ocular Surface Disease Index (OSDI), Current Symptoms Questionnaire (CSQ), meibomian gland score (MG score), and non-invasive tear breakup time (NIBUT).

RESULTS: Twenty-five participants completed the study (mean age 38±15 years, 7 male). There was a significant change in OSDI over time for the EyeBag group (mean[lower 95% CI, upper 95% CI], baseline: 39.1[31.1,47.0], 2wk: 26.8[19.7,33.9], 4wk: 26.6[16.5,36.7], 8wk: 27.7[18.4,37.0]; p=0.01), but not in the control group (p=0.22), but no significant difference between groups at all time points (all p>0.27). Symptoms immediately improved after conducting the EyeBag based on at-home CSQ scores (Δ=-5.0 points, p<0.01), but not in the control group. For both groups, there was no significant change (p-value EyeBag,p-value control) in MG score (0.21,0.17) and NIBUT (0.49,0.06) over time.

CONCLUSIONS: The EyeBag may relieve symptoms of dry eye, but the effect on meibomian gland function and tear stability when used for only 4 weeks was undetectable.

Nichols,J. J., Chalmers,R. L., Dumbleton,K., Jones,L., Lievens,C. W., Merchea,M. M., Szczotka-Flynn,L. The Case for Using Hydrogen Peroxide Contact Lens Care Solutions: A Review Eye & Contact Lens 2019;45(2):69-82 [ Show Abstract ]

Despite their established disinfection and safety benefits, the use of hydrogen peroxide (H2O2) lens care systems among today's wearers of reusable contact lenses remains low in comparison with multipurpose solution (MPS) use. Multipurpose solution systems, however, present several potential drawbacks that may impact patient outcomes, including the use of chemical preservatives for disinfection, biocompatibility issues, and challenges with respect to lens care compliance. Given their unique composition and mechanism of action, one-step H2O2 systems offer the opportunity to avoid many of the challenges associated with MPS use. This article reviews the evolution of H2O2 lens care systems and examines the current scientific and clinical evidence regarding the relative ease of use, lens and tissue compatibility, disinfection efficacy, and ocular surface safety of H2O2 systems. Evaluation of the available data indicates that in comparison with MPS, one-step H2O2 systems tend to promote more favorable compliance, efficacy, comfort, and ocular surface outcomes for a wide range of contact lens–wearing patients. Based on the current published evidence, the authors recommend that eye care practitioners consider making one-step H2O2 systems their first-line contact lens care recommendation for most wearers of reusable lenses.

Phan,C -M., Subbaraman,L., Jones,L. Uptake and release of polyvinyl alcohol from hydrogel daily disposable contact lenses Optom Vis Sci 2019;96(3):180-186 [ Show Abstract ]

SIGNIFICANCE:
Polyvinyl alcohol is a wetting agent that could reduce the symptoms of dry eye and contact lens discomfort. Currently, only one lens type, nelfilcon A (DAILIES AquaComfort Plus), releases polyvinyl alcohol. The concept of releasing this agent from contact lenses could be applied to other lens materials.

PURPOSE:
The purpose of this study was to measure the release of polyvinyl alcohol from commercially available hydrogel daily disposable contact lenses using refractive index and iodine-borate methods.

METHODS:
Etafilcon A, omafilcon A, and nelfilcon A were soaked in phosphate-buffered saline and 0.2% trifluoroacetic acid/acetonitile for 24 hours to remove residual blister pack components. The lenses were then incubated in a 10-mg/mL solution of polyvinyl alcohol for 24 hours. After the incubation period, the lenses were placed in 2 mL of phosphate-buffered saline. At specified time intervals, t = 0.5, 1, 2, 4, 8, 12, and 24 hours, the samples were evaluated using refractive index and an iodine-borate assay. Polyvinyl alcohol uptake was determined by extracting the lenses with methanol for 24 hours.

RESULTS:
There were no differences in the uptake of polyvinyl alcohol between lens types (P > .05). The release of this wetting agent for all lens types followed a burst-plateau profile after the first 30 minutes (P > .05). Nelfilcon A had a slightly higher release of polyvinyl alcohol (P < .05) than did etafilcon A but was similar to omafilcon A (P > .05).

CONCLUSIONS:
The results suggest that the contact lenses tested in this study have similar efficiency in delivering polyvinyl alcohol.

Phan,C -M., Walther,H., Riederer,D., Lau,C.,Lorentz,H., Subbaraman,L., Jones,L. Analysis of polyvinyl alcohol release from commercially available daily disposable contact lenses using an in vitro eye model J Biomed Mater Res B Appl Biomater 2019;107(5):1662-1668 [ Show Abstract ]

The purpose of this work was to determine the release of polyvinyl alcohol (PVA) from etafilcon A, omafilcon A, and nelfilcon A daily disposable hydrogel contact lenses using a novel in vitro model. PVA is an ocular lubricant that can be found in multiple formulations of artificial tears. Nelfilcon A innately contains PVA, so only the release of PVA from this lens was evaluated. Etafilcon A and omafilcon A lenses were incubated in a PBS solution containing PVA. The release of PVA was evaluated using a novel in vitro blink platform with Milli-Q water and PBS under various blink conditions and flow rates. Nelfilcon A lenses significantly released more PVA than other lenses at 0.5 and 1.5 h in both PBS and Milli-Q water (p < 0.001). For nelfilcon A, there was no statistical significance between the release profiles of PVA between the blink and no-blink conditions, or for the various flow rates (p > 0.05). All tested groups and lenses showed a burst release within the first 4.5 h and rapidly plateaued thereafter. The current study demonstrates that releasable PVA (whether through uptake or through being inherently available from the material) is loosely bound on hydrogel lenses, and the majority is released within 4.5 h.

Pucker,A. D., Jones-Jordan,L. A, Kunnen, C. M. E., Marx, S., Powell, D. R., Kwan, J.T., Srinivasan, S., Sickenberger, W., Jones, L. Impact of meibomian gland width on successful contact lens use 2019;Epub ahead of print [ Show Abstract ]

Purpose: To evaluate meibomian gland (MG) width and determine its impact on successful contact lens (CL) use and ocular health.
Methods: A five-site study was conducted by recruiting 18- to 45-year-old subjects who had dropped out of CLs because of discomfort. CL dropouts were compared to age- and sex-matched successful CL wearers. Right eyes were evaluated for tear break-up time, tear meniscus height, MG expressibility, meibum quality, and meibography. Central MG widths were evaluated with a custom MATLAB program.
Results: CL dropouts (n = 56) and successful CL (n = 56) wearers had similar grades for upper (p = 1.0) and lower (p = 0.22) MG atrophy, upper (p = 0.07) and lower (p = 0.89) MG tortuosity, and upper (p = 0.92) and lower (p = 0.97) MG widths. Upper eyelid MG widths were narrower than lower eyelid MG widths (p = 0.03). Upper and lower MG tortuosity (p < 0.001) and widths (p = 0.03) were associated, but not atrophy (p = 0.42). Lower eyelid MG widths were associated with MG expressibility (p = 0.01), but MG widths were not with any other factors.
Conclusions: Successful CL wear does not appear to be clinically influenced by MG width or other measures of MG structural integrity. Lower eyelid MGs were wider than upper eyelid MGs and narrower lower eyelid MGs were associated with worse MG expressibility, suggesting that narrower MGs may produce abnormal meibum. Data also suggests that MG factors of both eyelids should be evaluated in practice.

Pucker,A. D., Jones-Jordan,L. A., Marx,S., Powell,D. R., Kwan,J. T., Srinivasan,S., Sickenberger,W., Jones,L., Contact Lens Assessment of Symptomatic Subjects (CLASS) Study Group Clinical factors associated with contact lens dropout Cont Lens Anterior Eye 2019;42(3):318-324 [ Show Abstract ]

PURPOSE: Contact lens (CL) dropout is estimated to be approximately equal to the number of new wearers per year, resulting in virtually no growth in the global CL market. The purpose of this study was to determine ocular and CL factors associated with CL dropout.

METHODS: This five-site study recruited subjects 18-45 years of age who had ceased CL wear within the past 6-12 months due to discomfort. Dropout subjects were compared to age- and sex-matched currently successful CL wearers. Each subject was administered a symptoms survey and a study-specific survey that queried general CL history and compliance. Clinical testing included non-invasive tear break-up time, tear meniscus height, blepharitis assessment, meibum quality and expression, and meibography.

RESULTS: A total of 56 matched-pairs were recruited. Dry eye was found to significantly increase a subject's odds of dropping out of CLs. The odds of dropping out of CLs was also significantly increased with each worsening grade of upper or lower eyelid meibomian gland (MG) plugging, upper eyelid meibum quality, and upper eyelid MG tortuosity. No other factors analyzed increased a subject's odds of dropping out of CLs.

CONCLUSIONS: CL dropout may be precipitated by underlying dry eye symptoms, though most dry eye signs, with the exception of MG structure and function, had minimal predictive value for CL dropout. Nevertheless, evidence suggests that practitioners should screen for and educate CL patients about the importance of maintaining healthy MGs, which may potentially allow them to maintain comfortable CL use and increase their CL longevity.

Troilo,D., Smith,E. L. 3rd, Nickla,D. L., Ashby,R., Tkatchenko,A. V., Ostrin,L. A., Gawne,T. J., Pardue,M. T., Summers,J. A., Kee,C. S., Schroedl,F., Wahl,S., Jones,L. IMI - Report on Experimental Models of Emmetropization and Myopia Invest Ophthalmol Vis Sci 2019;60(3):M31-M88 [ Show Abstract ]

The results of many studies in a variety of species have significantly advanced our understanding of the role of visual experience and the mechanisms of postnatal eye growth, and the development of myopia. This paper surveys and reviews the major contributions that experimental studies using animal models have made to our thinking about emmetropization and development of myopia. These studies established important concepts informing our knowledge of the visual regulation of eye growth and refractive development and have transformed treatment strategies for myopia. Several major findings have come from studies of experimental animal models. These include the eye's ability to detect the sign of retinal defocus and undergo compensatory growth, the local retinal control of eye growth, regulatory changes in choroidal thickness, and the identification of components in the biochemistry of eye growth leading to the characterization of signal cascades regulating eye growth and refractive state. Several of these findings provided the proofs of concepts that form the scientific basis of new and effective clinical treatments for controlling myopia progression in humans. Experimental animal models continue to provide new insights into the cellular and molecular mechanisms of eye growth control, including the identification of potential new targets for drug development and future treatments needed to stem the increasing prevalence of myopia and the vision-threatening conditions associated with this disease.

Walther,H., Subbaraman,L. N., Jones,L. Efficacy of Contact Lens Care Solutions in Removing Cholesterol Deposits From Silicone Hydrogel Contact Lenses. Eye & Contact Lens 2019;45(2):105-111 [ Show Abstract ]

PURPOSE: To determine the efficacy of multipurpose solutions (MPSs) on the removal of cholesterol deposits from silicone hydrogel (SH) contact lens materials using an in vitro model.
MATERIALS AND METHODS: Five SH lens materials: senofilcon A, comfilcon A, balafilcon A, lotrafilcon A, and lotrafilcon B were removed from the blister pack (n=4 for each lens type), incubated for 7 days at 37°C in an artificial tear solution containing C radiolabeled cholesterol. Thereafter, lenses were stored in a preserved saline solution control (Sensitive Eyes Saline Plus) or cleaned with 1 of the 5 MPSs incorporating different preservatives (POLYQUAD/ALDOX, polyquaternium-1/alexidine, polyquaternium-1/PHMB, and 2 based on PHMB alone) using a rub and rinse technique, according to the manufacturer's recommendations, and stored in the MPS for a minimum of 6 hr. Lenses were then extracted with 2:1 chloroform:methanol, analyzed in a beta counter, and μg/lens of cholesterol was determined.
RESULTS: Balafilcon A and senofilcon A lens materials showed the highest amounts of accumulated cholesterol (0.93±0.02 μg/lens; 0.95±0.01 μg/lens, respectively), whereas lotrafilcon A and lotrafilcon B deposited the lowest amounts (0.37±0.03 μg/lens; 0.47±0.12 μg/lens, respectively). For all lens materials, the MPS preserved with POLYQUAD/ALDOX removed more deposited cholesterol than any other test solution; however, the amount of removed cholesterol contamination from the individual contact lenses was only statistically significant for balafilcon A and senofilcon A (P=0.006 and P=0.042, respectively). Sensitive eyes and the other evaluated MPSs showed no significant effect on cholesterol removal (P>0.05).
CONCLUSION: Cholesterol-removal efficacy varies depending on the combination of lens material and solution. Only 1 MPS showed a statistically significant reduction of cholesterol deposit for only 2 of the 5 tested lens materials.

Walther,H., Subbaraman,L. N., Jones,L. Novel in vitro method to determine pre-lens tear break-up time of hydrogel and silicone hydrogel contact lenses Cont Lens Anterior Eye 2019;42(2):178-184 [ Show Abstract ]

PURPOSE:
To develop an in vitro model to determine pre-lens non-invasive break-up time (NIBUT) and to subsequently use this method to compare the NIBUT over contemporary daily disposable (DD) contact lenses (CL).
METHODS:
Three silicone hydrogel (SH) and two conventional hydrogel (CH) DD CLs were incubated in an artificial tear solution (ATS). A model blink cell (MBC) was utilised to mimic intermittent air exposure. CLs were repeatedly submerged for 3 seconds (s) and exposed to air for 10 s over periods of 2, 6, 12, and 16 hours (h). NIBUTs (n = 4) were determined out of the blister pack (T0) and at the end of each incubation period.
RESULTS:
Overall, nesofilcon A showed the longest NIBUTs (p < 0.001). At T0, CHs revealed significantly longer NIBUTs (p ≤ 0.001) than SHs. After 2 h, nesofilcon A showed the longest NIBUT, however, this was only statistically significant compared with delefilcon A (p ≤ 0.001). After 6 h, nesofilcon A NIBUT was significantly longer than all other CLs (p ≤ 0.001). Etafilcon A showed a significantly longer NIBUT (p ≤ 0.001) after 12 h and delefilcon A had the longest NIBUT (p ≤ 0.001) after 16 h. Statistically significant (p ≤ 0.05) changes of NIBUT within the lens materials varied between time points. After 16 h, all CLs showed significant reductions in NIBUTs (p ≤ 0.001) in comparison to T0.
CONCLUSION:
NIBUT values reduced gradually over time and varying levels of deposition impacted measured pre-lens NIBUTs. While NIBUT of CH materials are longer immediately out of the blister pack, after tear film exposure, the NIBUTs obtained using this methodology became very similar.

Wolffsohn,J. S., Flitcroft,D. I., Gifford,K. L., Jong,M., Jones,L., Klaver,C.C.W., Logan,N.S., Naidoo,K., Resnikoff,S., Sankaridurg,P., Smith,E. L., Troilo,D., Wildsoet,C. F. IMI - Myopia Control Reports Overview and Introduction Invest Ophthalmol Vis Sci 2019;60(3):M1-M19 [ Show Abstract ]

With the growing prevalence of myopia, already at epidemic levels in some countries, there is an urgent need for new management approaches. However, with the increasing number of research publications on the topic of myopia control, there is also a clear necessity for agreement and guidance on key issues, including on how myopia should be defined and how interventions, validated by well-conducted clinical trials, should be appropriately and ethically applied. The International Myopia Institute (IMI) reports the critical review and synthesis of the research evidence to date, from animal models, genetics, clinical studies, and randomized controlled trials, by more than 85 multidisciplinary experts in the field, as the basis for the recommendations contained therein. As background to the need for myopia control, the risk factors for myopia onset and progression are reviewed. The seven generated reports are summarized: (1) Defining and Classifying Myopia, (2) Experimental Models of Emmetropization and Myopia, (3) Myopia Genetics, (4) Interventions for Myopia Onset and Progression, (5) Clinical Myopia Control Trials and Instrumentation, (6) Industry Guidelines and Ethical Considerations for Myopia Control, and (7) Clinical Myopia Management Guidelines.

Wolffsohn,J. S., Kollbaum,P. S., Berntsen,D. A., Atchison,D. A., Benavente,A., Bradley,A., Buckhurst,H., Collins,M., Fujikado,T., Hiraoka,T., Hirota,M., Jones,D., Logan,N. S., Lundström,L., Torii,H., Read,S. A., Naidoo,K. IMI - Clinical Myopia Control Trials and Instrumentation Report Invest Ophthalmol Vis Sci 2019;60(3):M132-M160 [ Show Abstract ]

The evidence-basis based on existing myopia control trials along with the supporting academic literature were reviewed; this informed recommendations on the outcomes suggested from clinical trials aimed at slowing myopia progression to show the effectiveness of treatments and the impact on patients. These outcomes were classified as primary (refractive error and/or axial length), secondary (patient reported outcomes and treatment compliance), and exploratory (peripheral refraction, accommodative changes, ocular alignment, pupil size, outdoor activity/lighting levels, anterior and posterior segment imaging, and tissue biomechanics). The currently available instrumentation, which the literature has shown to best achieve the primary and secondary outcomes, was reviewed and critiqued. Issues relating to study design and patient selection were also identified. These findings and consensus from the International Myopia Institute members led to final recommendations to inform future instrumentation development and to guide clinical trial protocols.

Wong,S., Srinivasan,S., Murphy,P.J., Jones,L. Comparison of meibomian gland dropout using two infrared imaging devices Cont Lens Anterior Eye 2019;42(3):311-317 [ Show Abstract ]

Purpose: To measure the degree of meibomian gland (MG) dropout in the lower eyelid determined by analysis of images obtained from the LipiView II (LVII) and the Keratograph 5M (K5M).

Methods: The inferior eyelid of each participant was imaged in a random order using both devices. All images were subjectively assessed by a single-masked investigator to determine the extent of MG loss using the Arita 4-point meiboscore grading scale. The images were also semi-objectively analyzed with ImageJ to calculate the percentage of MG dropout, by tracing around the non-glandular area and the total exposed area of the lower lid.

Results: Twenty participants (mean age 37 years, range 23–60, 60% female) completed the study. A significant difference in meiboscore (mean ± SD) was obtained between the LVII and the K5M (1.43 ± 0.78 vs. 1.90 ± 0.81, Z = 3.25, p = 0.001). The meiboscore 95% limit of agreement (LOA) ranged from −1.88 to +0.93. A significant difference was found with mean ImageJ percentage dropout between the LVII and the K5M (31.5% vs 43.4%, t = −4.8, p = 0.00003). The percentage dropout 95% LOA ranged from −42.79% to +19.06%.

Conclusions: LVII images had significantly lower meiboscores and less percentage MG dropout. Varying amounts of dropout were observed between the devices due the amount of eyelid that was typically everted and because of differences in image quality. These results indicate that these devices should not be used interchangeably to evaluate MG dropout.