Predicting the onset of myopia in children by age, sex, and ethnicity: Results from the CLEERE Study.

SIGNIFICANCE: Clinicians and researchers would benefit from being able to predict the onset of myopia for an individual child. This report provides a model for calculating the probability of myopia onset, year-by-year and cumulatively, based on results from the largest, most ethnically diverse study of myopia onset in the United States. PURPOSE: This study aimed to model the probability of the onset of myopia in previously nonmyopic school-aged children. METHODS: Children aged 6 years to less than 14 years of age at baseline participating in the Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study who were nonmyopic and less hyperopic than +3.00 D (spherical equivalent) were followed up for 1 to 7 years through eighth grade. Annual measurements included cycloplegic autorefraction, keratometry, ultrasound axial dimensions, and parental report of children's near work and time spent in outdoor and/or sports activities. The onset of myopia was defined as the first visit with at least -0.75 D of myopia in each principal meridian. The predictive model was built using discrete time survival analysis and evaluated with C statistics. RESULTS: The model of the probability of the onset of myopia included cycloplegic spherical equivalent refractive error, the horizontal/vertical component of astigmatism (J0), age, sex, and race/ethnicity. Onset of myopia was more likely with lower amounts of hyperopia and less positive/more negative values of J0. Younger Asian American females had the highest eventual probability of onset, whereas older White males had the lowest. Model performance increased with older baseline age, with C statistics ranging from 0.83 at 6 years of age to 0.92 at 13 years. CONCLUSIONS: The probability of the onset of myopia can be estimated for children in the major racial/ethnic groups within the United States on a year-by-year and cumulative basis up to age 14 years based on a simple set of refractive error and demographic variables.

Quality of life after wearing multifocal contact lenses for myopia control for 2 weeks in the BLINK Study.

PURPOSE: To validate Pediatric Refractive Error Profile 2 (PREP2) subscales that can be used to evaluate contact lens wearers and compare vision-specific quality of life measurements between children wearing multifocal and single vision contact lenses for 2 weeks. METHODS: Two hundred and ninety-four myopic children aged 7-11 years (inclusive) were enrolled in the 3-year, double-masked Bifocal Lenses In Nearsighted Kids (BLINK) Study. Participants completed the PREP2 survey after having worn contact lenses for 2 weeks. The Vision, Symptoms, Activities and Overall PREP2 subscales were used to compare participants' subjective assessment while wearing +1.50 or +2.50 D add multifocal or single vision contact lenses. Rasch analysis was used to validate each subscale and to compare participants' subjective assessment of contact lens wear. RESULTS: Item fit to the Rasch model was good for all scales, with no individual items having infit mean square statistics outside the recommended range (0.7-1.3). Response category function was acceptable for all subscales, with ordered category thresholds. Measurement precision, assessed by the Rasch person reliability statistic, was less than ideal (≥0.8) for three of the subscales, but met the minimum acceptable standard of 0.5. Scores for the Vision subscale differed by treatment assignment (p = 0.03), indicating that participants with the highest add power reported statistically worse quality of vision, although the difference was only 3.9 units on a scale of 1-100. Girls reported fewer symptoms than boys (p = 0.006), but there were no other differences between boys and girls. CONCLUSIONS: Rasch analysis demonstrates that the PREP2 survey is a valid instrument for assessing refractive error-specific quality of life. These results suggest that vision-related quality of life is not meaningfully affected by 2 weeks of soft multifocal contact lens wear for myopia control.

Vergence/accommodative therapy for symptomatic convergence insufficiency in children: Time course of improvements in convergence function.

PURPOSE: To evaluate the time course of improvements in clinical convergence measures for children with symptomatic convergence insufficiency treated with office-based vergence/accommodative therapy. METHODS: We evaluated convergence measures from 205, 9- to 14-year-old children with symptomatic convergence insufficiency randomised to office-based vergence/accommodative therapy in the Convergence Insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART). Near-point of convergence (NPC) and near-positive fusional vergence (PFV) were measured at baseline and after 4, 8, 12 and 16 weeks of therapy; mean change in NPC and PFV between these time points were compared using repeated measures analysis of variance. Rates of change in NPC and PFV from: (1) baseline to 4 weeks and (2) 4-16 weeks were calculated. For each time point, the proportion of participants to first meet the normal criterion for NPC (<6 cm), PFV blur (break if no blur; >15Δ and >2 times the exodeviation) and convergence composite (NPC and PFV both normal) were calculated. RESULTS: The greatest change in NPC and PFV (7.6 cm and 12.7 Δ) and the fastest rate of improvement in NPC and PFV (1.9 cm/week and 3.2 Δ/week, respectively) were both found during the first 4 weeks of therapy, with both slowing over the subsequent 12 weeks. After 12 weeks of therapy, the NPC, PFV and convergence composite were normal in 93.2%, 91.7% and 87.8% of participants, respectively, and normalised with another 4 weeks of therapy in 4.4%, 2.0% and 4.4% of participants, respectively. CONCLUSION: Although the greatest improvements in NPC and PFV occurred in the first 4 weeks of therapy, most participants had weekly improvements over the subsequent 12 weeks of treatment. While most children with convergence insufficiency obtained normal convergence following 12 weeks of therapy, an additional 4 weeks of vergence/accommodative therapy may be beneficial for some participants.

Effect of Combining 0.01% Atropine with Soft Multifocal Contact Lenses on Myopia Progression in Children.

SIGNIFICANCE: Combining 0.01% atropine with soft multifocal contact lenses (SMCLs) failed to demonstrate better myopia control than SMCLs alone. PURPOSE: The Bifocal & Atropine in Myopia (BAM) Study investigated whether combining 0.01% atropine and SMCLs with +2.50-D add power leads to greater slowing of myopia progression and axial elongation than SMCLs alone. METHODS: Participants of the BAM Study wore SMCLs with +2.50-D add power daily and administered 0.01% atropine eye drops nightly (n = 46). The BAM subjects (bifocal-atropine) were age-matched to 46 participants in the Bifocal Lenses in Nearsighted Kids Study who wore SMCLs with +2.50-D add power (bifocal) and 46 Bifocal Lenses in Nearsighted Kids participants who wore single-vision contact lenses (single vision). The primary outcome was the 3-year change in spherical equivalent refractive error determined by cycloplegic autorefraction, and the 3-year change in axial elongation was also evaluated. RESULTS: Of the total 138 subjects, the mean ± standard deviation age was 10.1 ± 1.2 years, and the mean ± standard deviation spherical equivalent was -2.28 ± 0.89 D. The 3-year adjusted mean myopia progression was -0.52 D for bifocal-atropine, -0.55 D for bifocal, and -1.09 D for single vision. The difference in myopia progression was 0.03 D (95% confidence interval [CI], -0.14 to 0.21 D) for bifocal-atropine versus bifocal and 0.57 D (95% CI, 0.38 to 0.77 D) for bifocal-atropine versus single vision. The 3-year adjusted axial elongation was 0.31 mm for bifocal-atropine, 0.39 mm for bifocal, and 0.68 mm for single vision. The difference in axial elongation was -0.08 mm (95% CI, -0.16 to 0.002 mm) for bifocal-atropine versus bifocal and -0.37 mm (95% CI, -0.46 to -0.28 mm) for bifocal-atropine versus single vision. CONCLUSIONS: Adding 0.01% atropine to SMCLs with +2.50-D add power failed to demonstrate better myopia control than SMCLs alone.

Ocular and Nonocular Adverse Events during 3 Years of Soft Contact Lens Wear in Children.

SIGNIFICANCE: Children are being fitted at younger ages with soft contact lenses for myopia control. This 3-year investigation of adverse events related to contact lens wear in 7- to 11-year-old participants helps optometrists understand what to expect when fitting children with soft contact lenses. PURPOSE: The purpose of this article is to report the frequency and type of ocular and nonocular adverse events related to soft contact lens wear in children. METHODS: Seven- to 11-year-old children wore soft contact lenses for 3 years. Adverse events were defined by a slit-lamp examination finding of grade 3 or worse; parental report of a clinically meaningful change (determined by the examiner) in eyes, vision, or health; or a clinically meaningful response (determined by examiner) to a symptom checklist. Adverse events were categorized and reported by examiners and finalized by the Executive Committee. The presence or absence of an infiltrate and a list of diagnoses was determined at the conclusion of the study. RESULTS: The 294 participants wore their contact lenses 73.0 ± 26.5 hours per week, and 220 (74.8%) encountered at least 1 adverse event. Of the 432 adverse events, 75.2% were ocular, and 24.8% were nonocular. Contact lens wear was probably or definitely related to 60.6% of the ocular and 2.8% of the nonocular adverse events. None of the ocular adverse events were serious or severe or caused permanent contact lens discontinuation. The corneal infiltrate incidence was 185 cases per 10,000 patient-years of wear (95% confidence interval, 110 to 294). The incidence of moderate ocular adverse events that were definitely or probably related to contact lens wear was 405 cases per 10,000 patient-years of wear (95% confidence interval, 286 to 557). CONCLUSIONS: The adverse events experienced by 7- to 11-year-old myopic children rarely required meaningful treatment and never led to permanent discontinuation of contact lens wear or loss of best-corrected vision.

Association between Vision Impairment and Physical Quality of Life Assessed Using National Surveillance Data.

SIGNIFICANCE: Physically unhealthy days assessments in national health surveillance datasets represent a useful metric for quantifying quality-of-life differences in those with and without vision impairment. Disproportionately poorer physical health in the visually impaired population provides further rationale for the inclusion of vision care in multidisciplinary approaches to chronic disease management. PURPOSE: This study aimed to assess the association between vision impairment and health-related quality of life using data from the Centers for Disease Control and Prevention's Behavioral Risk Factor Surveillance System. METHODS: Data from each of the 50 states were extracted from the 2017 Behavioral Risk Factor Surveillance System data set. Self-report of difficulty seeing was used to categorize visually impaired versus nonvisually impaired populations. Self-report number of physically unhealthy days in the previous 30 days was used to quantify quality of life. The number of unhealthy days was calculated for the visually impaired and nonvisually impaired cohorts for each state. The ratio of the number of physically unhealthy days in the visually impaired versus nonvisually impaired population was calculated for each state and for different age cohorts. RESULTS: Mean numbers of physically unhealthy days among persons with and without severe vision impairment across all states were 10.63 and 3.68 days, respectively, and demonstrated considerable geographic variability. Mean ratios of physically unhealthy healthy days in the visually impaired versus the nonvisually impaired population were 2.91 in the 18- to 39-year-old cohort, 2.87 in the 40- to 64-year-old cohort, and 2.16 in the ≥65-year-old cohort. CONCLUSIONS: National surveillance data demonstrate a greater number of physically unhealthy days in the visually impaired population, indicating a need to improve our understanding of causes that lead to reduced physical health among those with vision impairment. Additional research is needed to better understand how individuals perceive vision as part of their overall health.

Uncorrected Refractive Error and Distance Visual Acuity in Children Aged 6 to 14 Years.

SIGNIFICANCE: This study presents the relationship between distance visual acuity and a range of uncorrected refractive errors, a complex association that is fundamental to clinical eye care and the identification of children needing refractive correction. PURPOSE: This study aimed to analyze data from the Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error Study to describe the relationship between distance uncorrected refractive error and visual acuity in children. METHODS: Subjects were 2212 children (51.2% female) 6 to 14 years of age (mean ± standard deviation, 10.2 ± 2.1 years) participating in the Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error Study between 2000 and 2010. Uncorrected distance visual acuity was measured using a high-contrast projected logMAR chart. Cycloplegic refractive error was measured using the Grand Seiko WR-5100K autorefractor. The ability of logMAR acuity to detect various categories of refractive error was examined using receiver operating characteristic curves. RESULTS: Isoacuity curves show that increasing myopic spherical refractive errors, increasing astigmatic refractive errors, or a combination of both reduces distance visual acuity. Visual acuity was reduced by approximately 0.5 minutes of MAR per 0.30 to 0.40 D of spherical refractive error and by approximately 0.5 minutes of MAR per 0.60 to 0.90 D of astigmatism. Higher uncorrected hyperopic refractive error had little effect on distance visual acuity. Receiver operating characteristic curve analysis suggests that a logMAR distance acuity of 0.20 to 0.32 provides the best balance between sensitivity and specificity for detecting refractive errors other than hyperopia. Distance acuity alone was ineffective for detecting hyperopic refractive errors. CONCLUSIONS: Higher myopic and/or astigmatic refractive errors were associated with predictable reductions in uncorrected distance visual acuity. The reduction in acuity per diopter of cylindrical error was about half that for spherical myopic error. Although distance acuity may be a useful adjunct to the detection of myopic spherocylindrical refractive errors, accommodation presumably prevents acuity from assisting in the detection of hyperopia. Alternate procedures need to be used to detect hyperopia.

A randomised clinical trial of multifocal contact lenses and contact lens discomfort.

PURPOSE: To determine how multifocal contact lenses affect contact lens discomfort. METHODS: This randomised, participant-masked, crossover clinical trial fitted 84 uncomfortable soft contact lens wearers (30-40 years old) with single vision and multifocal contact lenses. Contact lens discomfort was assessed using the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8). RESULTS: There was no difference between multifocal and single vision survey scores (p = 0.08). There was an interaction between lens type and age group (p = 0.05). CLDEQ-8 scores with the single vision lens were less symptomatic than multifocal scores in participants <35 years old (p = 0.01). Single vision and multifocal scores for the older age group were not different. Subjectively, those in the <35 year-old age group preferred the single vision lens for intermediate (p = 0.02), distance (p = 0.003), and overall vision (p = 0.002). In the ≥35 year-old age group, no lens was significantly preferred for vision. CONCLUSIONS: Participants in the younger age group had more favourable wearing experiences with the single vision lens compared to the multifocal lens. The older age group, however, had similar wearing experiences with both lens types. While younger contact lens wearers may prefer the wearing experience with single vision lenses, some uncomfortable contact lens wearers approaching 40 years old may benefit from wearing a multifocal contact lens sooner in life than is typically practised.

Effectiveness of vergence/accommodative therapy for accommodative dysfunction in children with convergence insufficiency.

PURPOSE: To determine the effectiveness of office-based vergence/accommodative therapy for improving accommodative amplitude and accommodative facility in children with symptomatic convergence insufficiency and accommodative dysfunction. METHODS: We report changes in accommodative function following therapy among participants in the Convergence Insufficiency Treatment Trial - Attention and Reading Trial with decreased accommodative amplitude (115 participants in vergence/accommodative therapy; 65 in placebo therapy) or decreased accommodative facility (71 participants in vergence/accommodative therapy; 37 in placebo therapy) at baseline. The primary analysis compared mean change in amplitude and facility between the vergence/accommodative and placebo therapy groups using analyses of variance models after 4, 8, 12 and 16 weeks of treatment. The proportions of participants with normal amplitude and facility at each time point were calculated. The average rate of change in amplitude and facility from baseline to week 4, and from weeks 4 to 16, were determined in the vergence/accommodative therapy group. RESULTS: From baseline to 16 weeks, the mean improvement in amplitude was 8.6 dioptres (D) and 5.2 D in the vergence/accommodative and placebo therapy groups, respectively (mean difference = 3.5 D, 95% confidence interval (CI): 1.5 to 5.5 D; p = 0.01). The mean improvement in facility was 13.5 cycles per minute (cpm) and 7.6 cpm in the vergence/accommodative and placebo therapy groups, respectively (mean difference = 5.8 cpm, 95% CI: 3.8 to 7.9 cpm; p < 0.0001). Significantly greater proportions of participants treated with vergence/accommodative therapy achieved a normal amplitude (69% vs. 32%, difference = 37%, 95% CI: 22 to 51%; p < 0.0001) and facility (85% vs. 49%, difference = 36%, 95% CI: 18 to 55%; p < 0.0001) than those who received placebo therapy. In the vergence/accommodative therapy group, amplitude increased at an average rate of 1.5 D per week during the first 4 weeks (p < 0.0001), then slowed to 0.2 D per week (p = 0.002) from weeks 4 to 16. Similarly, facility increased at an average rate of 1.5 cpm per week during the first 4 weeks (p < 0.0001), then slowed to 0.6 cpm per week from weeks 4 to 16 (p < 0.0001). CONCLUSION: Office-based vergence/accommodative therapy is effective for improving accommodative function in children with symptomatic convergence insufficiency and coexisting accommodative dysfunction.

Effect of High Add Power, Medium Add Power, or Single-Vision Contact Lenses on Myopia Progression in Children: The BLINK Randomized Clinical Trial.

Importance: Slowing myopia progression could decrease the risk of sight-threatening complications. Objective: To determine whether soft multifocal contact lenses slow myopia progression in children, and whether high add power (+2.50 D) slows myopia progression more than medium (+1.50 D) add power lenses. Design, Setting, and Participants: A double-masked randomized clinical trial that took place at 2 optometry schools located in Columbus, Ohio, and Houston, Texas. A total of 294 consecutive eligible children aged 7 to 11 years with -0.75 D to -5.00 D of spherical component myopia and less than 1.00 D astigmatism were enrolled between September 22, 2014, and June 20, 2016. Follow-up was completed June 24, 2019. Interventions: Participants were randomly assigned to wear high add power (n = 98), medium add power (n = 98), or single-vision (n = 98) contact lenses. Main Outcomes and Measures: The primary outcome was the 3-year change in cycloplegic spherical equivalent autorefraction, as measured by the mean of 10 autorefraction readings. There were 11 secondary end points, 4 of which were analyzed for this study, including 3-year eye growth. Results: Among 294 randomized participants, 292 (99%) were included in the analyses (mean [SD] age, 10.3 [1.2] years; 177 [60.2%] were female; mean [SD] spherical equivalent refractive error, -2.39 [1.00] D). Adjusted 3-year myopia progression was -0.60 D for high add power, -0.89 D for medium add power, and -1.05 D for single-vision contact lenses. The difference in progression was 0.46 D (95% CI, 0.29-0.63) for high add power vs single vision, 0.30 D (95% CI, 0.13-0.47) for high add vs medium add power, and 0.16 D (95% CI, -0.01 to 0.33) for medium add power vs single vision. Of the 4 secondary end points, there were no statistically significant differences between the groups for 3 of the end points. Adjusted mean eye growth was 0.42 mm for high add power, 0.58 mm for medium add power, and 0.66 mm for single vision. The difference in eye growth was -0.23 mm (95% CI, -0.30 to -0.17) for high add power vs single vision, -0.16 mm (95% CI, -0.23 to -0.09) for high add vs medium add power, and -0.07 mm (95% CI, -0.14 to -0.01) for medium add power vs single vision. Conclusions and Relevance: Among children with myopia, treatment with high add power multifocal contact lenses significantly reduced the rate of myopia progression over 3 years compared with medium add power multifocal and single-vision contact lenses. However, further research is needed to understand the clinical importance of the observed differences. Trial Registration: ClinicalTrials.gov Identifier: NCT02255474.

Bifocal & Atropine in Myopia Study: Baseline Data and Methods.

SIGNIFICANCE: The Bifocal & Atropine in Myopia (BAM) study aims to determine whether combining 0.01% atropine and +2.50-diopter add center-distance soft bifocal contact lenses (SBCL) slows myopia progression more than SBCL alone. The results could provide significant information on the myopia control effect of combining optical and pharmacological treatments. PURPOSE: This article describes the subject characteristics at baseline, the study methods, and the short-term effects of this combination treatment on visual acuity (VA) and vision-related outcomes. METHODS: Subjects from the BAM study who met the baseline eligibility criteria were dispensed the combination treatment for 2 weeks to determine final eligibility. Outcome measures included VA at near and distance (Bailey-Lovie logMAR charts), near phoria (modified Thorington), accommodative lag (Grand Seiko WAM-5500), and pupil size (NeurOptics VIP-200 Pupillometer). Compliance was monitored using surveys. Two subgroups in the Bifocal Lenses In Nearsighted Kids study, single-vision contact lens wearers and those who wore +2.50-diopter add SBCL, will serve as the age-matched historical controls for BAM study. RESULTS: Forty-nine BAM subjects (9.6 ± 1.4 years) were enrolled; mean spherical equivalent cycloplegic autorefraction was -2.33 ± 1.03 diopters. After 2 weeks of treatment, the best-corrected low-contrast (10% Michelson) distance VA was reduced (pre-treatment, +0.09 ± 0.07; post-treatment, +0.16 ± 0.08; P < .0001), but the high-contrast VA at near or distance was unaffected. Near phoria increased by approximately 2 in the exo direction (P = .01), but the accommodative lag was unchanged. The pupil size was not significantly different between pre-treatment and post-treatment of either the photopic or mesopic condition. Surveys indicated that the subjects wore SBCL 77 ± 22% of waking hours and used atropine 6.4 ± 0.7 days per week. CONCLUSIONS: Two weeks of combination treatment reduced low-contrast distance VA and increased near exophoria slightly, but the subjects were compliant and tolerated the treatment well.

Visual Acuity and Over-refraction in Myopic Children Fitted with Soft Multifocal Contact Lenses.

SIGNIFICANCE: Practitioners fitting contact lenses for myopia control frequently question whether a myopic child can achieve good vision with a high-add multifocal. We demonstrate that visual acuity is not different than spectacles with a commercially available, center-distance soft multifocal contact lens (MFCL) (Biofinity Multifocal "D"; +2.50 D add). PURPOSE: To determine the spherical over-refraction (SOR) necessary to obtain best-corrected visual acuity (BCVA) when fitting myopic children with a center-distance soft MFCL. METHODS: Children (n = 294) aged 7 to 11 years with myopia (spherical component) of -0.75 to -5.00 diopters (D) (inclusive) and 1.00 D cylinder or less (corneal plane) were fitted bilaterally with +2.50 D add Biofinity "D" MFCLs. The initial MFCL power was the spherical equivalent of a standardized subjective refraction, rounded to the nearest 0.25 D step (corneal plane). An SOR was performed monocularly (each eye) to achieve BCVA. Binocular, high-contrast logMAR acuity was measured with manifest spectacle correction and MFCLs with over-refraction. Photopic pupil size was measured with a pupilometer. RESULTS: The mean (±SD) age was 10.3 ± 1.2 years, and the mean (±SD) SOR needed to achieve BCVA was OD: -0.61 ± 0.24 D/OS: -0.58 ± 0.27 D. There was no difference in binocular high-contrast visual acuity (logMAR) between spectacles (-0.01 ± 0.06) and best-corrected MFCLs (-0.01 ± 0.07) (P = .59). The mean (±SD) photopic pupil size (5.4 ± 0.7 mm) was not correlated with best MFCL correction or the over-refraction magnitude (both P ≥ .09). CONCLUSIONS: Children achieved BCVA with +2.50 D add MFCLs that was not different than with spectacles. Children typically required an over-refraction of -0.50 to -0.75 D to achieve BCVA. With a careful over-refraction, these +2.50 D add MFCLs provide good distance acuity, making them viable candidates for myopia control.

A Randomized Trial of Soft Multifocal Contact Lenses for Myopia Control: Baseline Data and Methods.

SIGNIFICANCE: The Bifocal Lenses In Nearsighted Kids (BLINK) study is the first soft multifocal contact lens myopia control study to compare add powers and measure peripheral refractive error in the vertical meridian, so it will provide important information about the potential mechanism of myopia control. PURPOSE: The BLINK study is a National Eye Institute-sponsored, double-masked, randomized clinical trial to investigate the effects of soft multifocal contact lenses on myopia progression. This article describes the subjects' baseline characteristics and study methods. METHODS: Subjects were 7 to 11 years old, had -0.75 to -5.00 spherical component and less than 1.00 diopter (D) astigmatism, and had 20/25 or better logMAR distance visual acuity with manifest refraction in each eye and with +2.50-D add soft bifocal contact lenses on both eyes. Children were randomly assigned to wear Biofinity single-vision, Biofinity Multifocal "D" with a +1.50-D add power, or Biofinity Multifocal "D" with a +2.50-D add power contact lenses. RESULTS: We examined 443 subjects at the baseline visits, and 294 (66.4%) subjects were enrolled. Of the enrolled subjects, 177 (60.2%) were female, and 200 (68%) were white. The mean (± SD) age was 10.3 ± 1.2 years, and 117 (39.8%) of the eligible subjects were younger than 10 years. The mean spherical equivalent refractive error, measured by cycloplegic autorefraction was -2.39 ± 1.00 D. The best-corrected binocular logMAR visual acuity with glasses was +0.01 ± 0.06 (20/21) at distance and -0.03 ± 0.08 (20/18) at near. CONCLUSIONS: The BLINK study subjects are similar to patients who would routinely be eligible for myopia control in practice, so the results will provide clinical information about soft bifocal contact lens myopia control as well as information about the mechanism of the treatment effect, if one occurs.

Associations with Meibomian Gland Atrophy in Daily Contact Lens Wearers.

PURPOSE: To determine associations for contact lenses (CLs) and meibomian gland atrophy in a matched-pair study. METHODS: Contact lens wearers (case) and age- and sex-matched non-contact lens (NCL) wearers with no history of CL use (control) were recruited for a multicenter study. All subjects were administered the Ocular Surface Disease Index questionnaire and a comprehensive battery of clinical tests (e.g., tear breakup time, bulbar and limbal redness, meibography, etc.) were performed. Upper and lower eyelid meibomian gland atrophy were graded with both digital meibography (percent gland atrophy) and visual meiboscore methods. Conditional logistic regression analyses were then used to determine relationships among CL use, meibomian gland atrophy, and ocular surface signs and symptoms. RESULTS: A total of 70 matched pairs were analyzed. The mean (± SD) age of the CL group was 30.6 (± 12.4) years, and that of the NCL group was 30.1 (± 12.2) years. The subjects were 63% female. The association between CL wear and meiboscore was not significant univariately, but the best-fitting multivariate regression model showed that higher meiboscores were associated with being a CL wearer (odds ratio [OR], 2.45) in a model that included eyelid margin erythema (OR, 0.25) and lissamine green staining (OR, 1.25). Percent gland atrophy was not associated with CL wear in regression analysis (p = 0.31). CONCLUSIONS: This study determined inconclusive associations with CLs and meibomian gland atrophy. This study also provided a comprehensive assessment of differences between CL and NCL wearers.

The risk of microbial keratitis with overnight corneal reshaping lenses.

PURPOSE: To estimate the incidence of microbial keratitis (MK) associated with overnight corneal reshaping contact lenses and to compare rates in children and adults. METHODS: A retrospective study of randomly selected practitioners, stratified by order volume and lens company, was conducted. Practitioners were invited to participate and those agreeing were asked to provide deidentified patient information for up to 50 lens orders and to complete a comprehensive event form for any of these patients who have attended an unscheduled visit for a painful red eye. Duration of contact lens wear was calculated from the original fitting date or January 2005 (whichever was later) to when the patient was last seen by the practitioner wearing the lenses on a regular basis. Cases of MK were classified by majority decision of a 5-member expert panel. RESULTS: For the 191 practitioners who could be contacted, 119 (62%) agreed to participate. Subsequently, 11 withdrew, 22 did not respond, and 86 (43%) returned completed forms corresponding to 2202 lens orders and 1494 patients. Limiting the sample to those patients with at least 3 months of documented contact lens wear since 2005 resulted in a sample of 1317 patients; 640 adults (49%) and 677 children (51%) representing 2599 patient-years of wear (adults = 1164; children = 1435). Eight events of corneal infiltrates associated with a painful red eye were reported (six in children and two in adults). Two were classified as MK. Both occurred in children but neither resulted in a loss of visual acuity. The overall estimated incidence of MK is 7.7 per 10,000 years of wear (95% confidence interval [CI] = 0.9 to 27.8). For children, the estimated incidence of MK is 13.9 per 10,000 patient-years (95% CI = 1.7 to 50.4). For adults, the estimated incidence of MK is 0 per 10,000 patient-years (95% CI = 0 to 31.7). CONCLUSIONS: The risk of MK with overnight corneal reshaping contact lenses is similar to that with other overnight modalities. The fact that the CIs for the rates estimated overlap should not be interpreted as evidence of no difference. True differences fewer than 50 cases per 10,000 patient-years were beyond the study's power of detection.

Multifocal contact lens myopia control.

PURPOSE: Previous studies on soft multifocal contact lens myopia control published in the peer-reviewed literature reported findings of noncommercial contact lenses worn for 1 year or less. This study sought to determine the progression of myopia and axial elongation of children fitted with commercially available distance center soft multifocal contact lenses for 2 years. METHODS: Eight- to eleven-year-old children with -1.00 D to -6.00 D spherical component and less than 1.00 D astigmatism were fitted with soft multifocal contact lenses with a +2.00 D add (Proclear Multifocal "D"; CooperVision, Fairport, NY). They were age- and gender-matched to participants from a previous study who were fitted with single-vision contact lenses (1 Day Acuvue; Vistakon, Jacksonville, FL). A-scan ultrasound and cycloplegic autorefraction were performed at baseline, after 1 year, and after 2 years. Multilevel modeling was used to compare the rate of change of myopia and axial length between single-vision and soft multifocal contact lens wearers. RESULTS: Forty participants were fitted with soft multifocal contact lenses, and 13 did not contribute complete data (5 contributed 1 year of data). The adjusted mean ± standard error spherical equivalent progression of myopia at 2 years was -1.03 ± 0.06 D for the single-vision contact lens wearers and -0.51 ± 0.06 for the soft multifocal contact lens wearers (p < 0.0001). The adjusted mean axial elongation was 0.41 ± 0.03 and 0.29 ± 0.03 for the single-vision and soft multifocal contact lens wearers, respectively (p < 0.0016). CONCLUSIONS: Soft multifocal contact lens wear resulted in a 50% reduction in the progression of myopia and a 29% reduction in axial elongation during the 2-year treatment period compared to a historical control group. Results from this and other investigations indicate a need for a long-term randomized clinical trial to investigate the potential for soft multifocal contact lens myopia control.

Peripheral Defocus, Pupil Size, and Axial Eye Growth in Children Wearing Soft Multifocal Contact Lenses in the BLINK Study.

Purpose: The purpose of this study was to evaluate the relationship between peripheral defocus and pupil size on axial growth in children randomly assigned to wear either single vision contact lenses, +1.50 diopter (D), or +2.50 D addition multifocal contact lenses (MFCLs). Methods: Children 7 to 11 years old with myopia (-0.75 to -5.00 D; spherical component) and ≤1.00 D astigmatism were enrolled. Autorefraction (horizontal meridian; right eye) was measured annually wearing contact lenses centrally and ±20 degrees, ±30 degrees, and ±40 degrees from the line of sight at near and distance. Photopic and mesopic pupil size were measured. The effects of peripheral defocus, treatment group, and pupil size on the 3-year change in axial length were modeled using multiple variables that evaluated defocus across the retina. Results: Although several peripheral defocus variables were associated with slower axial growth with MFCLs, they were either no longer significant or not meaningfully associated with eye growth after the treatment group was included in the model. The treatment group assignment better explained the slower eye growth with +2.50 MFCLs than peripheral defocus. Photopic and mesopic pupil size did not modify eye growth with the +2.50 MFCL (all P ≥ 0.37). Conclusions: The optical signal causing slower axial elongation with +2.50 MFCLs is better explained by the lens type worn than by peripheral defocus. The signal might be something other than peripheral defocus, or there is not a linear dose-response relationship within treatment groups. We found no evidence to support pupil size as a criterion when deciding which myopic children to treat with MFCLs.

Predictors of adequate correction following vision screening failure.

PURPOSE: To determine whether compliance with referral 1 year after vision screening failure was associated with care model, demographic, or ocular factors. METHODS: Data were analyzed from 798 children in the Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error Study with habitual logMAR visual acuity (VA) ≥0.26 (20/40 + 2 or worse) in either eye due to uncorrected or undercorrected refractive error and who returned the following year. The parents of 492 children failing in TX and CA were sent letters indicating the need for a complete vision examination (screening model), while 306 children seen primarily in AZ and AL received a free complete examination and eyeglasses if needed (complete care model). Presenting to follow-up with adequate correction (logMAR <0.26) in each eye was considered compliant. Logistic regression models for compliance were fit to assess whether care model, ethnicity, sex, age, uncorrected logMAR in the better eye, or parental income, education, or myopia were predictors. RESULTS: Overall compliance was 28%. Age [p = 0.01, odds ratio (OR) = 1.12] and uncorrected logMAR (p < 0.001, OR = 1.13) were associated with compliance but care model, ethnicity, and sex were not. Among the 447 children for whom data on parental factors were available, 27% were compliant. In this model, age, ethnicity, sex, parental income, parental education, and parental myopia were not associated with compliance, but uncorrected logMAR (p = 0.005; OR = 1.13) was predictive. An interaction between unaided VA and care model predicted improved compliance with poorer unaided VA in the complete care model. CONCLUSIONS: Expensive complete care screening programs may not improve compliance over typical notification and referral screening protocols in school-aged children, unless unaided VA is worse than the common 20/40 referral criteria. Unaided VA had less impact on predicted compliance in the screening-only protocol.