Digital Eye Strain: Updated Perspectives.

Purpose: Digital eye strain (DES) is a growing worldwide concern because digital devices are prevalent in both our work and home lives. The purpose of this review was to summarize clinically relevant and evolving key topics related to DES. Methods: A PubMed.gov search was conducted on or before June 8, 2024. No date restrictions were used during the primary search. The search was aimed at detecting all articles related to DES; thus, the search terms only included "digital eye strain" or "computer vision syndrome". Results: The two most used, validated DES questionnaires are the Computer Vision Syndrome Questionnaire (CVS-Q) and Computer Vision Symptom Scale (CVSS17). The world-wide prevalence of DES ranges from 8.2% to 100% depending upon the subjects evaluated and the method used to evaluate them. The most common DES symptoms include headache, eye strain, eye redness, eye itching, tearing, photophobia, burning sensation, blurred vision, eye pain, neck and shoulder pain, and eye dryness. Ocular surface symptoms in DES are integrally tied to decreased blink frequency, which causes ocular surface desiccation, increased osmolarity, and dry eye-like symptoms. The most studied DES-specific treatments are improving subjects' environment, artificial tears, blinking exercises, and near work breaks. Conclusion: DES is a highly prevalent condition that should be regularly screened for in clinic with a validated diagnosis instrument. While there are several treatment options, the community's treatment approach is evolving and primarily focused on treating the visual and dry eye-like symptoms associated with the condition.

Lubricating drops for contact lens discomfort in adults.

BACKGROUND: Contact lens discomfort is a symptom-based clinical diagnosis that affects 13% to 75% of contact lens wearers. The Tear Film and Ocular Surface Society defines contact lens discomfort as "a condition characterized by episodic or persistent adverse ocular sensations related to lens wear either with or without visual disturbance, resulting from reduced compatibility between the lens and ocular environment, which can lead to decreased wearing time and discontinuation from lens wear." Signs of the condition include conjunctival hyperemia, corneal and conjunctival staining, altered blinking patterns, lid wiper epitheliopathy, and meibomian gland dysfunction. Eye care specialists often treat contact lens discomfort with lubricating drops, including saline, although there is no clear evidence showing this treatment is effective and safe. OBJECTIVES: To evaluate the efficacy and safety of lubricating drops for ocular discomfort associated with contact lens wear in adults. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register), MEDLINE, Embase.com, two other databases, and two trials registries to May 2024, without date or language restrictions. SELECTION CRITERIA: We included parallel-group randomized controlled trials (RCTs) that evaluated lubricating drops, including saline, versus no treatment, or that evaluated lubricating drops versus saline, in adult contact lens wearers. We included studies regardless of publication status, language, or year of publication. DATA COLLECTION AND ANALYSIS: We applied standard Cochrane methodology. The critical outcome was contact lens discomfort. Important outcomes were corneal fluorescein staining and conjunctival redness. Adverse outcomes were incident microbial keratitis, inflammatory corneal infiltrates, and participant discontinuation. We assessed risk of bias for outcomes reported in the summary of findings table using the Cochrane risk of bias tool RoB 2, and we rated the certainty of the evidence using GRADE. MAIN RESULTS: We included seven RCTs conducted in the USA, Canada, Italy, and France. They randomized a total of 463 participants to lubricating drops, saline, or no treatment. Four trials evaluated lubricating drops and saline versus no treatment, but one of them provided no usable outcome data. Three trials evaluated lubricating drops versus saline. Study characteristics All trial participants were adults, and the mean age ranged from 25.7 years to 36.7 years. The proportion of women varied from 15% to 82%. The trials lasted between one and four weeks. Of the five trials that reported contact lens discomfort, we judged three at high risk of bias, and considered the other two had some risk of bias concerns. Lubricating drops (including saline) versus no treatment Lubricating drops compared with no treatment may reduce contact lens discomfort, measured on a 37-point scale (lower is better), but the evidence is very uncertain (mean difference [MD] -5.9 points, 95% confidence interval [CI] -3.74 to -8.05; 2 RCTs; 119 participants). One trial found no difference between lubricating drops and no treatment in "end-of-day" comfort. The trial that compared saline with no treatment provided no results for the control group. Two studies measured corneal fluorescein staining on a scale of 0 to 20 (lower is better). We found low-certainty evidence of little to no difference between lubricating drops and no treatment in changes in the extent (MD -0.15 points, 95% CI -0.86 to 0.56; 2 RCTs; 119 participants), depth (MD -0.01 points, 95% CI -0.44 to 0.42; 2 RCTs; 119 participants), or type (MD 0.04 points, 95% CI -0.38 to 0.46; 2 RCTs; 119 participants) of corneal fluorescein staining scores. Regarding conjunctival redness, measured on a scale of 0 to 4 (lower is better), there was low-certainty evidence of little to no difference between lubricating drops and no treatment in nasal region scores (MD 0.10, 95% CI -0.29 to 0.49; 1 RCT; 73 participants) and temporal region scores (MD 0.00, 95% CI -0.39 to 0.39; 1 RCT; 73 participants). No studies reported microbial keratitis or inflammatory corneal infiltrates, and no trials reported vision-threatening adverse events up to four weeks of treatment. All trials reported the proportion of participants who discontinued participation. In two trials, no participants left any treatment group. Our meta-analysis of another two studies suggests little difference in the number of people who dropped out of the lubricating treatment group versus the no treatment group (risk ratio [RR] 1.42, 95% CI 0.19 to 10.94; 138 participants; low-certainty evidence). Lubricating drops versus saline Lubricating drops may have little to no effect compared with saline on contact lens discomfort measured on a visual analog scale of 0 to 100 (lower is better), but the evidence is very uncertain (MD 9.5 points, 95% CI -4.65 to 23.65; 1 RCT; 39 participants). No studies reported corneal fluorescein staining or conjunctival redness. No studies reported microbial keratitis or inflammatory corneal infiltrates, and no trials reported vision-threatening adverse events up to four weeks of treatment. Our meta-analysis of three studies suggests little difference in the number of people who dropped out of the lubricating treatment group versus the saline group (RR 1.56, 95% CI 0.47 to 5.12; 269 participants; low-certainty evidence). AUTHORS' CONCLUSIONS: Very low-certainty evidence suggests that lubricating drops may improve contact lens discomfort compared with no treatment, but may have little or no effect on contact lens discomfort compared with saline. Low-certainty evidence also suggests that lubricating drops may have no unwanted effects that would lead to discontinuation over one to four weeks. Current evidence suggests that prescribing lubricating drops (including saline) to people with contact lens discomfort is a viable option. However, most studies did not assess patient-reported contact lens (dis)comfort using a validated instrument. Therefore, further well-designed trials are needed to generate high-certainty evidence on patient-reported outcomes as well as on longer-term safety outcomes.

Running the enrollment numbers on ophthalmic clinical trials in the United States.

SIGNIFICANCE: This is one of the first reports to summarize the enrollment metrics for ophthalmology trials completed in the United States (US). PURPOSE: This study aimed to describe US ophthalmology clinical trial enrollment metrics to facilitate planning and budgeting of US Food and Drug Administration-regulated ophthalmological drugs trials. METHODS: A GlobalData PLC search was conducted on or before February 27, 2024, to evaluate the clinical trial landscape for completed ophthalmology clinical trials conducted in the US. The primary search contained only the term "ophthalmology," which was restricted to trials that were completed and were conducted within the US. Trials were classified as multicenter when trials included three sites or more, and when the enrollment search resulted in ≥30 multicenter trials for an individual indication, enrollment data were further broken down by Food and Drug Administration trial phase. RESULT: The search yielded 2229 trials, which analyzed 980 different drugs produced by 854 different sponsors. The most common indications evaluated in US trials were macular degeneration, glaucoma, macular edema, allergies, and keratoconjunctivitis. Multicenter trials by indication had an overall median enrollment period range of 4.8 to 35.1 months; number of subjects enrollment, range of 36 to 518 subjects; number of sites utilized, range of 4 to 74 sites; and enrollment rate, range of 0.11 to 4.04 subjects/sites per month. There were 17 indications with ≥30 multicenter trials, which allowed for enrollment metric calculation by trial phase. CONCLUSIONS: This study provides sponsors with an understanding of the number of subjects and sites needed to complete a trial while also setting realistic enrollment timelines. Although this work represents the US market, more work is needed to better understand other countries given that country-specific guidelines and subject beliefs may impact enrollment metrics.

Silicone hydrogel versus hydrogel soft contact lenses for differences in patient-reported eye comfort and safety: A Cochrane systematic review summary.

SIGNIFICANCE: This work is significant because it is the first Cochrane systemic review that compares the comfort and safety of hydrogel and silicone hydrogel soft contact lenses (SCL). PURPOSE: This study aimed to conduct a systemic review of randomized trials comparing the comfort and safety of silicone hydrogel and hydrogel SCLs. METHODS: CENTRAL, MEDLINE Ovid, EMBASE.com, PubMed, LILACS, ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform were searched on or before June 24, 2022, to identify randomized clinical trials that compared silicone hydrogel and hydrogel SCLs. RESULTS: Seven trials were identified and evaluated. One trial reported Ocular Surface Disease Index results, with the evidence being very uncertain about the effects of SCL material on Ocular Surface Disease Index scores (mean difference, -1.20; 95% confidence interval, -10.49 to 8.09). Three trials reported visual analog scale comfort score results, with no clear difference in comfort between materials, although results were of low certainty; trial results could not be combined because the three trials reported results at different time points. None of the included trials reported Contact Lens Dry Eye Questionnaire 8 or Standard Patient Evaluation of Eye Dryness scores. There was no evidence of a clinically meaningful difference (>0.5 unit) between daily disposable silicone hydrogel and hydrogel SCLs in corneal staining, conjunctival staining, or conjunctival redness (very low certainty evidence). CONCLUSIONS: The overall evidence for a difference between all included silicone hydrogel and hydrogel SCL trials was of very low certainty, with most trials judged as having a high overall risk of bias. There was insufficient evidence to support recommending one SCL material over the other. Future well-designed trials are needed to generate high certainty evidence to further clarify differences in SCL material comfort and safety.

Comparing meibomian gland visibility on optical coherence tomography and Keratograph 5M images using objective and subjective grading methods.

PURPOSE: To investigate if there is a visible difference in meibomian gland (MG) length between images captured with the Visante optical coherence tomography (OCT; wavelength = 1,310 nm) and the OCULUS Keratograph 5M (K5M; wavelength = 880 nm). METHODS: Adults between 18 and 40 years were recruited. Baseline dry eye disease was evaluated with the Standard Patient Evaluation of Eye Dryness (SPEED) and tear meniscus height and tear breakup time with the K5M. Right upper and lower eyelid MGs were imaged with the K5M and Visante OCT. Each image was graded with the 0 to 3 meiboscore scale. The central 5 MGs were evaluated with ImageJ for percent gland length visibility. RESULTS: Thirty participants were analyzed with a median (interquartile range [IQR]) age of 23.0 (5.0) years (53.3 % female). Overall, participants were asymptomatic and had normal tear films. Meiboscores based on K5M and Visante OCT was significantly different for the lower eyelid (0[1] vs 1[2]; p = 0.007) but not the upper eyelid (0[1] vs 0[1]; p = 1.00). The mean percent gland visibility of the upper eyelid (82.7[9.6] vs 75.2[13.5]; p < 0.001) and the lower eyelid (81.2[12.7] vs 64.1[17.6]; p < 0.001) were significantly greater on the Visante OCT than the K5M images, respectively. CONCLUSION: OCT images had significantly greater percent visible MG lengths than the K5M images. This suggests viable segments of the MGs may be missed with typical imaging, which may explain how it is possible that studies have found less post-treatment MG atrophy.

Refitting contact lens dropouts into a modern daily disposable contact lens.

PURPOSE: To determine the number of previous contact lens (CL) wearers who could be comfortably refitted into delefilcon A (DAILIES TOTAL1®) CLs. METHODS: This was a 6-month, three-visit study that recruited subjects who discontinued CLs within the past 2 years because of discomfort or dryness symptoms. Subjects were required to have Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire scores ≤3 and to be able to wear spherical study CLs. Subjects were asked to complete a ±50 comfort visual analogue scale (VAS) at 1 month and a Likert questionnaire after 1 and 6 months of CL wear to understand the subjects' CL experience. RESULTS: All 60 subjects who were fitted with the study CLs were still wearing them after 1 month, while one subject had dropped out by 6 months. Subjects had a median (interquartile range) age of 24.0 (7.0) years (71.7% female). They reported a median VAS score of 44.0 (8.0) units at the 1-month visit, with all reporting a comfortable score. At the 1-month/6-month visits, 98.3%/93.2%, 86.5%/78.0% and 93.2%/91.5% of subjects responded that they were very satisfied or satisfied with their vision, their end-of-day CL comfort and overall CL comfort, respectively. The same subjects responded that they were very likely or likely to continue to wear the study CLs at 1 (89.6%) and 6 months (80.7%) and to recommend the study CLs to a friend at 1 (98.3%) and 6 months (93.2%). CONCLUSIONS: The results suggest that when encountering a CL dropout, a practitioner could educate a patient about trying an alternative CL and consider delefilcon A lenses as an option.

LipiFlow for the treatment of dry eye disease.

BACKGROUND: Meibomian gland dysfunction (MGD) is the most common underlying cause of dry eye disease (DED). MGD leads to pathological alteration of the composition or quantity of meibum, or both, which subsequently results in tear evaporation and the typical signs and symptoms associated with DED. The LipiFlow Thermal Pulsation System (LipiFlow) is a medical device used to treat MGD in office; however, it is unclear if LipiFlow can outperform other DED treatments. OBJECTIVES: To evaluate the effectiveness of LipiFlow for treating DED signs and symptoms and the safety of LipiFlow compared with sham or other available treatments for MGD in adults. SEARCH METHODS: The Cochrane Eyes and Vision Information Specialist searched the electronic databases for randomized controlled trials. There were no restrictions on language or date of publication. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, including the Cochrane Eyes and Vision Trials Register; 2022, Issue 6), MEDLINE Ovid, Embase.com, PubMed, LILACS (Latin American and Caribbean Health Science Information database), ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) electronic databases. We also examined the reference lists of identified trials, review articles, and guidelines for information about relevant trials that may not have been identified by our search strategy. We contacted investigators regarding ongoing trials. The last database search was performed on 24 October 2022. SELECTION CRITERIA: We included studies conducted in adults (over 18 years of age) with DED or MGD as defined by the primary trial investigators. We imposed no restrictions on race, ethnicity, or sex. We considered trials involving contact lens wearers if they were equally represented between groups. DATA COLLECTION AND ANALYSIS: We applied standard Cochrane methodology. MAIN RESULTS: We included 13 trials that randomized a total of 1155 participants (28 to 236 participants randomized per study). Six trials were conducted in the USA, three in China, two in Thailand, one in France, and one in Italy. Eight trials were of single-center design, while four trials were of multicenter design; one trial did not report the number of participating centers. Study characteristics The study population of the included trials was 66% female (range 48% to 80%), with an age range of 19 to 86 years. LipiFlow, used as a stand-alone intervention, was compared with basic warm compresses in five studies, thermostatic device in five studies, oral intervention in one trial, and topical dry eye medications in one trial. LipiFlow was also evaluated together with eyelid hygiene product versus eyelid hygiene products alone in one trial. Findings Five trials compared LipiFlow with a basic warm compress applied for varying durations and frequencies during the trial period; only one of these trials combined a warm compress with eyelid massage. Analyzing symptom scores by different questionnaires (Ocular Surface Disease Index [OSDI] and Standard Patient Evaluation of Eye Dryness [SPEED]) yielded conflicting evidence of a difference in symptoms between LipiFlow and basic warm compresses after four weeks. There was no evidence of a difference in meibomian gland expression, meibum quality, or tear breakup time when comparing LipiFlow with basic warm compresses. Another five trials compared LipiFlow with thermostatic devices. Analysis of symptom scores at four weeks showed that thermostatic devices had reduced OSDI scores by a mean difference (MD) of 4.59 (95% confidence interval [CI] 1.23 to 7.95; I2 = 0, P = 0.007; 553 participants; very low certainty evidence) as compared with LipiFlow. When we compared LipiFlow plus eyelid hygiene with eyelid hygiene alone, there was no evidence of difference in signs or symptoms at any time point evaluated. Only one trial compared LipiFlow with a topical DED medication (lifitegrast 5%). The single-trial estimate suggested that 5% lifitegrast may increase meibomian gland expression scores compared with LipiFlow at day 42 (MD -1.21, 95% CI -2.37 to -0.05; 50 participants; low certainty evidence) by using a meibomian gland expression scale of 0 to 8. One trial compared LipiFlow with an oral intervention (doxycycline), finding that LipiFlow may result in significantly better SPEED scores than doxycycline at three months (MD -4.00, 95% CI -7.33 to -0.67; 24 participants; very low certainty evidence). No other significant differences in signs or symptoms were found between LipiFlow and doxycycline at three months. We did not find any other statistically significant differences in symptoms or signs for any other analysis performed in this review at the one- to four-week time point. Adverse events No trial reported any intervention-related, vision-threatening adverse events. AUTHORS' CONCLUSIONS: LipiFlow performs similarly to other commonly used DED treatments with regard to DED signs and symptoms. The best available evidence was deemed to have a high level of bias, leading to low or very low certainty evidence. Additional research with adequate masking, a standardized testing methodology, and a sample representative of the MGD population is therefore needed before any firm conclusions can be drawn regarding comparative benefits and harms.

Silicone hydrogel versus hydrogel soft contact lenses for differences in patient-reported eye comfort and safety.

BACKGROUND: Ocular discomfort is the leading cause of permanent discontinuation of soft contact lens (SCL) wear. Silicone hydrogel and hydrogel materials are the two major categories of SCLs, with silicone hydrogel materials being newer and more breathable than hydrogel materials. Whether comfort is associated with SCL material is controversial despite numerous studies. Similarly, the difference between these materials in terms of safety outcomes (e.g. frequency of microbial keratitis) is unclear. OBJECTIVES: To evaluate the comparative effectiveness and safety of silicone hydrogel compared with hydrogel SCLs on self-reported comfort, dry eye test results, and adverse events in SCL-wearing adults 18 years of age or older. SEARCH METHODS: The Cochrane Eyes and Vision Information Specialist searched the electronic databases for randomized controlled trials (RCTs). There were no restrictions on language or date of publication. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, including the Cochrane Eyes and Vision Trials Register; 2022, Issue 6), MEDLINE Ovid, Embase.com, PubMed, LILACS (Latin American and Caribbean Health Science Information database), ClinicalTrials.gov, and World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We also searched the reference lists of identified studies, review articles, and guidelines for information about relevant studies that may not have been identified by our search strategy. Furthermore, we contacted investigators regarding ongoing trials. The most recent database search was conducted on 24 June 2022. SELECTION CRITERIA: Our search selection criteria included RCTs, quasi-RCTs, and cross-over RCTs. DATA COLLECTION AND ANALYSIS: We applied standard Cochrane methodology. MAIN RESULTS: We included seven parallel-group RCTs conducted in the USA, the UK, Australia, Germany, India, and Turkey. A total of 1371 participants were randomized. The duration of SCL wear ranged from one to 52 weeks. Study characteristics and risk of bias The median number of participants per trial was 120 (interquartile range: 51 to 314), and the average age ranged from 20.7 to 33.0 years. Women represented the majority of participants (range 55% to 74.9%; 5 RCTs). Collectively, the included trials compared eight different silicone hydrogel SCLs with three different hydrogel SCLs. Five trials compared daily disposable SCLs, and two compared extended wear SCLs (worn for seven days and six nights). New SCL wearers were enrolled in three trials. Two trials included both new and established SCL wearers, and two trials did not report participants' history of SCL use. Five trials were sponsored by industry. We judged the overall risk of bias to be 'high' or 'some concerns' for the safety and efficacy outcomes. Findings One trial reported Ocular Surface Disease Index (OSDI) results, with the evidence being very uncertain about the effects of SCL material on OSDI scores (mean difference -1.20, 95% confidence interval [CI] -10.49 to 8.09; 1 RCT, 47 participants; very low certainty evidence). Three trials reported visual analog scale comfort score results, with no clear difference in comfort between materials, but the evidence was of very low certainty; trial results could not be combined because the three trials reported results at different time points. The evidence is very uncertain about the effect of SCL material on discontinuation of contact lens wear (risk ratio [RR] 0.64, 95% CI 0.11 to 3.74; 1 RCT, 248 participants). None of the included trials reported Contact Lens Dry Eye Questionnaire (CLDEQ-8) or Standard Patient Evaluation of Eye Dryness (SPEED) scores. There was no evidence of a clinically meaningful difference (> 0.5 unit) between daily disposable silicone hydrogel and hydrogel SCLs in corneal staining, conjunctival staining, or conjunctival redness (very low certainty evidence). Adverse events Very low certainty evidence from two trials comparing daily disposable SCLs suggested no evidence of a difference between lens materials in the risk of vision-threatening adverse events at one to four weeks (RR 0.68, 95% CI 0.08 to 5.51; 2 RCTs, 368 participants). Two trials comparing extended wear SCLs indicated that hydrogel SCLs may have a 2.03 times lower risk of adverse events at 52 weeks compared with silicone hydrogel SCLs (RR 2.03, 95% CI 1.38 to 2.99; 815 participants), but the certainty of evidence was very low. AUTHORS' CONCLUSIONS: The overall evidence for a difference between all included silicone hydrogel and hydrogel SCLs was of very low certainty, with most trials at high overall risk of bias. The majority of studies did not assess comfort using a validated instrument. There was insufficient evidence to support recommending one SCL material over the other. For extended wear, hydrogel SCL may have a lower risk of adverse events at 52 weeks compared to silicon hydrogel. Future well-designed trials are needed to generate high certainty evidence to further clarify differences in SCL material comfort and safety.

Real-Time Ocular Comfort Reporting in Monthly Replacement Contact Lens Wearers.

Purpose: To map contact lens (CL) comfort over the full wear day and across 1 month's wear in established, asymptomatic to minimally symptomatic, reusable, soft CL wearers. Methods: Adult, 18- to 45-year-old, participants were recruited and required to have 20/20 best-corrected visual acuity or better and must have been asymptomatic to minimally symptomatic CL wearers. Participants were required to be able to wear TOTAL30® sphere CLs and have minimal astigmatism. Participants were fit in the study CLs and asked to wear these CLs daily for the next month for 16 hours per day each day. Participants were asked to complete a visual analog scale (VAS) survey via text message at time of CL application and after 8, 10, 12, 14, and 16 hours of wear and at CL removal on days 1, 2, 3, 4, and 5 and at 2 weeks and 1 month. The utilized VAS had a ±50 scale with positive scores being comfortable, negative scores being uncomfortable, and scores of 0 being neutral comfort. Results: Forty-eight participants were recruited who had a mean ± SD age of 26.2 ± 5.2 years (71% female). Mean initial VAS CL comfort scores at initial CL dispense were 45.56 ± 9.20 units. Mean CL wear times for any of the days evaluated were at least 14.80 ± 2.41 hours per day and did not differ across the study (p = 0.77). Mean comfort VAS scores significantly decreased over the wear day (all days p ≤ 0.02), yet there were no significant differences in VAS comfort scores across the same time of day for the duration of the study (all times p ≥ 0.06). Conclusion: This study determined that while CL wearers were slightly less comfortable at the end of the day compared to application, this comfort change was minimal given that the average participants had overwhelmingly good comfort at all time-points evaluated. Comfort scores were likewise consistent across 1 month of wear.

Validation of a Modified National Eye Institute Grading Scale for Corneal Fluorescein Staining.

Purpose: Validation of the novel Lexitas modified NEI scale for use in assessment of corneal fluorescein staining. Patients and Methods: A series of 18 illustrations and 14 clinical photographs depicting varying severity levels of corneal fluorescein staining were assessed by 3 independent examiners. Regions of the cornea were graded for staining severity based on 3 different grading scales: the original NEI staining scale (density-based scoring; 0-3 scale), a structured version of the NEI scale (dot-count scoring; 0-3 scale), and the Lexitas modified NEI staining scale (0-4 scale with half-point increments). Kappa statistics (simple and weighted) were computed to determine intra-examiner image grading repeatability for each examiner over 2 separate assessments. Inter-examiner assessment reliability utilized the scores from the first read of each examiner, and pairs of examiners to compute kappa statistics. Results: Data was analyzed from the scores provided by the examiners from each gradable corneal region on 32 images (18 illustrations and 14 photographs) for a total of 154 corneal regions across the 3 grading scales for each validation run. The mean intra-examiner simple/weighted kappa values using the NEI density, NEI dot count, and the Lexitas modified NEI staining scales were 0.67/0.72, 0.91/0.94, 0.80/0.92 for the graded illustrations, and 0.83/0.88, 0.76/0.85, 0.77/0.88 for the graded photographs, respectively. The mean inter-examiner simple/weighted kappa values using the NEI density, NEI dot count, and the Lexitas modified NEI staining scales were 0.59/0.65, 0.86/0.90, and 0.78/0.91 for the graded illustrations, and 0.80/0.88, 0.84/0.89, 0.69/0.88 for the graded photographs, respectively. Conclusion: The expanded scale of the Lexitas modified NEI staining scale demonstrated a high degree of reliability and repeatability of grading assessments within and across individual examiners, comparing favorably with the original NEI staining scale. A future investigation into the in-office utility of the Lexitas modified NEI staining scale is warranted.

Quality of Life in Digital Device Users Who are Treated with Systane Hydration PF.

Purpose: To understand the impact of Systane Hydration PF on dryness symptoms and quality of life in digital device users and to determine if participants prefer either the unit-dose or multi-dose dispensing system of Systane Hydration PF. Materials and Methods: This 2-week, three visit study recruited regular digital device users. Participants were required to score ≤80 on the Impact of Dry Eye on Everyday Life (IDEEL) Quality of Life (QoL) Work domain and between 13 and 32 on the Ocular Surface Disease Index (OSDI) questionnaire. Participants were randomized to either Systane Hydration PF unit-dose or multi-dose for 1 week and switched to the alternative dosing system for the second week. Participations were evaluated by completing the full IDEEL-QoL module and OSDI questionnaire at each visit. Likert surveys were completed to probe dispensing system preferences. Results: Thirty participants with a mean ± SD age of 28.6 ± 12.0 years (70% female) were recruited. Participants had significant improvements in all three IDEEL-QoL domains as well as in OSDI scores (all p < 0.0001). Participants had similar preferences for the two dispensing systems, though they were more likely to indicate that they thought that the multi-dose bottle was more environmentally friendly than the unit-dose vials. Conclusion: Digital device users with dry eye symptoms had meaningful improvements in eye comfort and quality of life scores after being treated with Systane Hydration PF for 2 weeks. Participants did not have a clear dispensing system preference suggesting that the best dispensing system may depend on the patient.

Fighting Myopia with Intermittent Nearwork Breaks: 20 Seconds Every 20 Minutes Might Not Be Enough Time.

SIGNIFICANCE: Practitioners commonly prescribe the 20/20/20 rule with hopes that, if patients follow it, they will reduce their myopic progression. This clinical perspective provides evidence that 20-second break from nearwork every 20 minutes are not enough time to impact ocular growth.The ongoing myopia epidemic is a major public health crisis. Although the correlation between nearwork tasks such as reading, computers, and smartphones and myopia development is controversial, multiple lines of research suggest that sustained nearwork contributes to myopia development. Clinicians have proposed that children should take short breaks from nearwork with a 20-second break every 20 minutes being a common suggestion. Animal model data do strongly support the idea that multiple short breaks across time can cancel out the effects of longer periods of myopia-promoting activities. However, the animal model data also suggest that repeated episodes of 20 seconds are ineffective at reducing myopia development and instead indicate that sustained breaks of 5 minutes or more every hour are needed to negate myopiagenic effects.

Determining initial ocular comfort differences between 0.7% olopatadine and 0.035% ketotifen fumarate.

PURPOSE: To compare the ocular comfort at application of topical, over-the-counter, 0.7% olopatadine and 0.035% ketotifen fumarate anti-allergy eye drops. METHODS: This study recruited participants who were minimally symptomatic based upon Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire scores (≤3 units) and who had minimal between-eye inter-ocular comfort differences as judged by visual analog scale scores (VAS; ≤7 units). Baseline comfort was evaluated by eye with a VAS. One drop of 0.7% olopatadine or 0.035% ketotifen fumarate was then applied to the right eye with the alternative drop being immediately applied to the left eye. Participants were next evaluated with the same comfort VAS by eye at drop application, and then at 30 s, 1 min, and 2 min post-application. LogMAR visual acuities and bulbar conjunctival redness were evaluated pre- and post-drop application to judge initial changes. RESULTS: This study enrolled 159 participants who had a mean ± SD age of 26.3 ± 7.7 years, and 78.6% of the participants were female. The VAS found that the 0.7% olopatadine drop was more comfortable than the 0.035% ketotifen fumarate drop at all time-points. There were no between-eye differences in LogMAR visual acuities, yet bulbar redness was significantly less in 0.7% olopatadine treated eyes compared 0.035% ketotifen fumarate treated eyes. CONCLUSION: This study found that topically applied 0.7% olopatadine drops were initially more comfortable than 0.035% ketotifen fumarate drops.

Understanding ocular comfort differences between 0.7% olopatadine and 0.3% pheniramine maleate/0.025% naphazoline hydrochloride eye drops.

CLINICAL RELEVANCE: This study found 0.7% olopatadine (Pataday Once Daily Relief Extra Strength) eye drops to provide better initial comfort than 0.3% pheniramine maleate/0.025% naphazoline hydrochloride (VISINE® Allergy Eye Relief Multi-Action Antihistamine and Redness Reliever) eye drops suggesting that patients may comply better with the Pataday than VISINE. BACKGROUND: To compare the ocular comfort at instillation of Pataday and VISINE allergy eye drops. METHODS: Minimally symptomatic participants were recruited based upon Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire scores (≤3 units); they also had minimal between-eye inter-ocular comfort differences as judged by visual analogue scale scores (VAS; ≤7 units). Baseline comfort was evaluated by eye with a VAS. One drop of Pataday or VISINE was then applied to the right eye with the alternative drop being applied to the left eye. The same VAS evaluated comfort by eye at drop instillation, and then at 30 seconds, 1 minute, and 2 minutes post-instillation. Drop experience was also evaluated with Likert questions. LogMAR visual acuities and bulbar conjunctival redness were evaluated pre- and post-drop instillation. RESULTS: A total of 159 participants were recruited (mean ± SD age = 26.2 ± 7.5). The VAS found that eyes treated with Pataday were significantly more comfortable at instillation than eyes treated with VISINE. Likert questions indicated that participants significantly preferred Pataday drops compared to the VISINE drops at instillation with regards to overall eye comfort, eye stinging, eye burning, and foreign body sensation. There were no between drop differences in visual acuity, though eyes treated with VISINE were less red than eyes treated with Pataday. CONCLUSIONS: Topically applied Pataday drops were more comfortable than VISINE drops.

Tear Film miRNAs and Their Association With Human Dry Eye Disease.

PURPOSE: miRNAs can regulate inflammatory pathways. The purpose of this work was to determine if inflammatory-related tear film miRNAs are associated with extracellular vesicles (EVs) in human non-Sjögren's Syndrome dry eye disease (DED) participants. METHODS: Five DED and 5 non-DED human participants were recruited. Tears samples were collected by washing the ocular surface of both eyes with phosphate buffered saline, pooling samples from the right and left eyes, and purifying EVs from the samples with a polyethylene glycol (PEG) 8000 precipitation procedure. Samples were directly analyzed via ELISA or transmission electron microscopy (TEM), or RNA was isolated first from the EVs and evaluated with RNA-Seq. RESULTS: EVs were identified in the tear film of both groups using TEM and ELISA. Following EV purification and RNA isolation, RNA-Seq determined that there were 126 EV miRNAs differentially expressed between the two groups when comparing their RNA cargoes. Ingenuity Pathways Analysis found 9 upregulated miRNAs that were associated with inflammation (miR-127-5p, miR-1273h-3p, miR-1288-5p, miR-130b-5p, miR-139-3p, miR-1910-5p, miR-203b-5p, miR-22-5p, and miR-4632-3p; all p < 0.049; fold regulation range = 1.43-1.67). CONCLUSION: This study determined that EVs are present in the tear film and that tear EVs contain miRNAs that may be associated with DED inflammatory pathways.

Identifying the content, functionalities, and features of a mobile application for contact lens wearers.

BACKGROUND: Lack of attention to end-users' requirements and preferences may lead to the failure of health information technology (IT) interventions. Identifying users' needs for designing a mobile application can lead to the development of an acceptable intervention. This study aimed to determine the requirements for designing a mobile application to educate and provide needed information to contact lens (CL) wearers. METHODS: A qualitative study was conducted on 24 CL wearers and nine eye care practitioners from the three CL clinics in Iran. Data were collected through semi-structured interviews and analyzed using the conventional content analysis proposed by Lundman and Graneheim. Lincoln and Guba's criteria were used to ensure the trustworthiness of the data. RESULTS: The three main categories that emerged from the interviews were mobile application content, mobile application functionalities, and mobile application features. Ten subcategories and 57 sub-subcategories were also identified. It was determined that mobile content should focus on advice and information for optimizing the CL wearing experience and training regarding the use of CLs. Entering information required for self-care, computational capability, interactivity, updates, and reminders were determined as needed functionalities. The participants recommended features for the structure and user interface of the mobile application and information presentation methods. CONCLUSION: This study identified the information needed to develop a mobile application for CL wearers. This also provides insights regarding required functionalities when applying IT interventions. These findings can be used by CL clinics, developers of health information systems, policymakers, and health planners to design better CL-related care and compliance interventions.

Morphological characteristics of Meibomian Glands and their Influence on Dry Eye disease in contact lens wearers.

PURPOSE: Meibomian glands (MG) are now easily imaged via clinical meibography machines. The purpose of this work was to explore the utility of the known MG morphology metrics for predicting dry eye disease (DED) in contact lens (CL) wearers. METHODS: Successful and previous CL wearers were recruited. DED was diagnosed if the participant's worst eye had a reduced tear meniscus height (TMH) of <0.2 mm or non-invasive tear break-up time (NITBUT) of <10 s and a Standardized Patient Evaluation of Eye Dryness (SPEED) score >5.0. Meibography was performed and images were subjectively graded by two examiners for the following MG characteristics: distorted, tortuous, hooked, abnormal gap, overlapping, fluffy areas, tadpoling, thinned, thickened, ghost, no extension to lid margin, shortened and dropout (atrophy). DED diagnostic ability of each metric was determined with receiver operating characteristic (ROC) analysis. RESULTS: A total of 112 participants were recruited, with 18.8% having DED and 60.7% being female. The only MG morphology metrics that were marginally predictive of DED were thickened upper eyelid MGs (p = 0.046), thickened mean upper plus lower eyelid MGs (p = 0.007), and atrophy of upper eyelid MGs (p = 0.043); however, none of these metrics reached a meaningful area under the curve in ROC analysis (all <0.70). CONCLUSION: While abnormal MG morphology is likely suggestive of DED in CL wearers, none of the MG morphology metrics evaluated alone in this study had clinically meaningful predictive value for detecting DED in this group of current and previous CL wearers.

A review of meibomian gland structure, function, and contact lens wear.

PURPOSE: To provide a balanced literature review of the studies that have evaluated the effect of contact lenses on meibomian gland (MG) health. METHODS: A PubMed.gov literature search was conducted on or before May 15, 2021. No other time constraints were applied. Search terms included the following: "meibomian gland(s)" plus "contact lens(es)" or "meibography" plus "contact lens(es)". Only full text articles written in English were considered. The reference lists of recovered papers were used to identify articles missed during the primary search. Included articles were required to discuss the impact of contact lenses on MG morphology or function and were graded according to the level of evidence presented. RESULTS: The literature indicates that contact lenses impact MG function; however, the data are equivocal regarding contact lenses inducing MG structural changes. The literature likewise indicates that the mechanism(s) by which contact lenses impact the MGs are likely multifactorial. Recent data suggests that MGs may have some plasticity. Detected differences between studies likely stem from varied populations evaluated, study designs, and the duration of the evaluation periods. CONCLUSIONS: With this literature review finding conflicting relationships between MG health and contact lens use, future longitudinal studies with standardized clinical MG assessments are needed to determine the true impact of contact lenses on MG health. Until these data are obtained, contact lens wearers should undergo a full MG evaluation, especially because recent data suggest that MG treatments may restore MG structure and function.

Common Ophthalmic Preservatives in Soft Contact Lens Care Products: Benefits, Complications, and a Comparison to Non-Preserved Solutions.

PURPOSE: Preservatives are essential for preventing contact lens (CL)-related microbial keratitis (MK). The purpose of this review is to summarize the current knowledge related to the use of common ophthalmic preservatives in CL care products with respect to both safety and efficacy. METHODS: Manuscripts written in English were obtained by searching PubMed.gov with the term contact lens plus antimicrobial, benzalkonium chloride, biguanide, Aldox, polyquaternium, preservative, thimerosal, EDTA (ethylenediaminetetraacetic acid), chlorhexidine, or blister pack. RESULTS: This review found that first-generation preservatives are no longer used in CL multipurpose solutions (MPS) due to their high levels of ocular toxicity. Modern, high-molecular-weight preservatives, including polyquaternium-1 (PQ-1) and biguanides (PHMB), are generally effective against bacteria, minimally effective against fungi, and not effective against Acanthamoeba. PQ-1 and PHMB are likely safe when used with CLs, but they may cause ocular adverse events, with roughly equal risk between the two preservatives. Some CL MPS contain both PQ-1 and PHMB, but no increased risk of adverse events has been reported when combining the two. Hydrogen-peroxide (H2O2) solutions are effective against all common ocular microbes, including Acanthamoeba, and they have been proven safe with proper compliance. Povidone-iodine (P-I) solutions are not currently commercially available in North America, but they have been shown in other countries to be safe and effective. CONCLUSION: Patients should be monitored when using PQ-1 or PHMB-containing solutions since they have been associated with ocular adverse events. If events are detected, patients should be switched to an alternative solution. H2O2 or P-I solutions are preferred for any patient who may expose their CLs to water because they are the only solution categories effective against Acanthamoeba.