Intraocular Straylight and Multifocal Soft Contact Lens Fit With a Myopia Control Approach.

OBJECTIVES: Center-distance multifocal contact lenses (MFCLs) are used to slow myopia progression. We examined the effect of two MFCLs on intraocular straylight values in myopic individuals. METHODS: Twenty-five young myopic adults were enrolled and were fit with three contact lenses (Biofinity sphere, Biofinity Multifocal, and NaturalVue Multifocal) in a random order over two study visits. Pupil size (NeurOptics VIP-300, Laguna Hills, CA) and contact lens centration were measured. Right eye intraocular straylight measurements were collected (OCULUS C-Quant; Wetzlar, Germany) and compared with a spectacle trial lens. Log straylight (LogSL) values and straylight residuals were analyzed using repeated-measures analyses of variance with Tukey-corrected post hoc t -tests. RESULTS: The mean participant age (±SD) was 24.1±1.5 years, and right eye spherical equivalent refractive error was -3.38±1.53 DS. There was no difference in mesopic pupil size between visits ( P =0.68) and no difference in contact lens centration between lenses ( P =0.99). LogSL values differed by lens type ( P =0.004). LogSL with the spectacle trial lens was significantly greater than with each contact lens type (all P <0.05), but there were no significant differences in LogSL between the three contact lenses (all P >0.05). There was no difference between the three contact lens designs for straylight residuals ( P =0.33). CONCLUSIONS: Measured intraocular straylight for both MFCLs was not different than with a spherical soft contact lens. A significant increase in intraocular straylight with spectacle trial lens correction was observed compared with all contact lenses.

Accommodation in Children after 4.7 Years of Multifocal Contact Lens Wear in the BLINK Study Randomized Clinical Trial.

SIGNIFICANCE: When worn for myopia control in children, soft multifocal contact lenses with a +2.50 D add reduced the accommodative response over a 3-year period, but wearing them for more than 4 years did not affect accommodative amplitudes, lag, or facility. PURPOSE: This study aimed to compare the accommodative response to a 3D stimulus between single-vision, +1.50-D add, and +2.50-D add multifocal contact lens wearers during 3 years of contact lens wear and then to compare accommodative amplitude, lag, and facility between the three groups after an average of 4.7 years of wear. METHODS: Bifocal Lenses In Nearsighted Kids study participants aged 7 to 11 years old were randomly assigned to wear single-vision, +1.50-D add, or +2.50-D add soft contact lenses (CooperVision, Pleasanton, CA). The accommodative response to a 3D stimulus was measured at baseline and annually for 3 years. After 4.7 years, we measured objective accommodative amplitudes, lead/lag, and binocular facility with ±2.00-D flippers. We compared the three accommodative measures using multivariate analysis of variance (MANOVA), adjusting for clinic site, sex, and age group (7 to 9 or 10 to 11 years). RESULTS: The +2.50-D add contact lens wearers exhibited lower accommodative response than the single-vision contact lens wearers for 3 years, but the +1.50-D add contact lens wearers exhibited only lower accommodative response than did the single-vision contact lens wearers for 2 years. After adjustment for clinic site, sex, and age group, there were no statistically significant or clinically meaningful differences between the three treatment groups for accommodative amplitude (MANOVA, P = .49), accommodative lag (MANOVA, P = .41), or accommodative facility (MANOVA, P = .87) after an average of 4.7 years of contact lens wear. CONCLUSIONS: Almost 5 years of multifocal contact lens wear did not affect the accommodative amplitude, lag, or facility of children.

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.

Contrast Sensitivity with Center-distance Multifocal Soft Contact Lenses.

SIGNIFICANCE: The contrast sensitivity (CS) function provides a more detailed assessment of vision than visual acuity. It was found that center-distance multifocal contact lens designs that are increasingly being prescribed for myopia control reduce distance photopic and mesopic CS in nonpresbyopic patients across a range of spatial frequencies. PURPOSE: This study aimed to determine the effect of center-distance multifocal soft contact lenses (MFCLs) on CS under photopic and mesopic conditions in nonpresbyopic patients. METHODS: Twenty-five myopic, nonpresbyopic adults were fitted binocularly with three lenses: Biofinity single vision contact lens (SVCL), Biofinity Multifocal D +2.50 add, and NaturalVue Multifocal in random order. Contrast sensitivity was measured at distance (4 m) under photopic and mesopic conditions and at near under photopic conditions. Log CS by spatial frequency and area under the log contrast sensitivity function (AULCSF) were analyzed between lenses. RESULTS: Distance photopic CS at each spatial frequency was higher with the SVCL than the MFCLs (P < .001), but there was no difference between the MFCLs (P = .71). Distance mesopic CS from 1.5 to 12 cycles per degree (cpd) was higher with the SVCL than the MFCLs (all P < .02); however, at 18 cpd, there was no difference in CS between NaturalVue and the SVCL (P = .76), possibly because of spurious resolution. Photopic AULCSF for the SVCL was roughly 10% greater than both MFCLs. Contrast sensitivity at near was generally similar between lenses, only slightly lower with the NaturalVue at 11 and 15.5 cpd, but AULCSF at near was not different between lenses (P > .05). CONCLUSIONS: Multifocal contact lenses reduce distance contrast sensitivity under both photopic and mesopic conditions. There is no clinically significant difference in near CS among all three lenses. These data show that MFCLs have effects on vision that are not captured by standard high-contrast visual acuity testing.

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.

The Effects of Center-near and Center-distance Multifocal Contact Lenses on Peripheral Defocus and Visual Acuity.

SIGNIFICANCE: Multifocal contact lenses (MFCLs) are being used clinically for myopia control. Center-distance designs caused myopic changes in defocus across the retina that varied by lens design, whereas the center-near design caused peripheral hyperopic changes. Multifocal lenses caused reductions in low-contrast vision that varied by lens design, affecting visual performance. PURPOSE: The purpose of this study was to compare changes in defocus with four MFCLs, three center-distance and one center-near. METHODS: Two cohorts of 25 nonpresbyopic myopic adults were enrolled. The first cohort was fitted with Proclear D and Biofinity D MFCL (center-distance, +2.50 D add), and the second cohort was fitted with NaturalVue MFCL (center-distance) and Clariti 1-Day MFCL (center-near, high add), both in random order. Overrefraction was performed to maximize visual acuity. Cycloplegic autorefraction was performed with each lens and without a lens along the line of sight and at nasal and temporal retinal locations out to 40°. Data were analyzed with repeated-measures ANOVAs with post hoc t tests, when indicated. RESULTS: Changes in defocus at each location differed between MFCL designs (lens by location; both, P < .001). Clariti 1-Day caused peripheral hyperopic retinal changes (40 and 30° nasal, and 20, 30, and 40° temporal; all, P < .05). NaturalVue MFCL caused myopic changes centrally and hyperopic changes at 40° nasal and 30° temporal (all, P < .05). The remaining center-distance designs caused myopic changes at multiple locations (all, P < .05). CONCLUSIONS: After overrefraction, the center-near MFCL design caused hyperopic defocus at multiple peripheral locations, which is not hypothesized to slow myopia progression. NaturalVue MFCL caused myopic changes in defocus centrally but hyperopic changes in the far periphery. Biofinity D and Proclear D caused myopic changes in retinal defocus. Further work is warranted to determine whether defocus profile differences between the center-distance designs influence any slowing of myopia progression.

Visual Performance of Center-distance Multifocal Contact Lenses Fit Using a Myopia Control Paradigm.

PURPOSE: The purpose of this study was to examine the visual performance of center-distance MFCLs in nonpresbyopic adults under different illumination and contrast conditions compared with a single-vision contact lens (SVCL). METHODS: Twenty-five adult subjects were fit with three different lenses (CooperVision Biofinity D MFCL +2.50 add, Visioneering Technologies NaturalVue MFCL, CooperVision Biofinity sphere). Acuity and reading performance were evaluated. RESULTS: A statistically significant difference in high-contrast distance acuity was observed (Biofinity, -0.18 ± 0.06; Biofinity MFCL, -0.14 ± 0.08; NaturalVue MFCL, -0.15 ± 0.03; repeated-measures [RM] ANOVA, P = .02). Under mesopic, high-contrast conditions, MFCLs performed worse than SVCLs (Biofinity, -0.05 ± 0.091; Biofinity MFCL, +0.03 ± 0.09; NaturalVue MFCL, +0.05 ± 0.091; RM-ANOVA, P < .0001). Under low-contrast conditions, MFCLs performed one line worse in photopic lighting and two lines worse under mesopic conditions (RM-ANOVA, P < .0001). Glare reduced acuity by 0.5 logMAR for all lenses (RM-ANOVA, P < .001). A statistically significant difference in near acuity was observed (RM-ANOVA, P = .02), but all lenses achieved acuity better than -0.1 logMAR (Biofinity, -0.16 ± 0.06; Biofinity MFCL, -0.17 ± 0.04; NaturalVue MFCL, -0.13 ± 0.08). Reading performance in words per minute (wpm) was worse with MFCLs (Biofinity MFCL, 144 ± 22 wpm; NaturalVue MFCL, 150 ± 28 wpm) than with SVCLs (156 ± 23 wpm; RM-ANOVA, P = .02) regardless of letter size (RM-ANOVA, P = .13). No difference in acuity between the MFCLs was detected (RM-ANOVA: all, P > .05). CONCLUSIONS: Multifocal contact lenses perform similarly to SVCLs for high-contrast targets and display reduced low-contrast acuity and reading speed. Practitioners should recognize that high-contrast acuity alone does not describe MFCL visual performance.

Power profiles of centre-distance multifocal soft contact lenses.

PURPOSE: Centre-distance multifocal contact lenses (MFCLs) for myopia control are thought to slow myopia progression by providing both clear foveal vision and myopic defocus. Characterising the power profile of lenses is important to understanding their possible effects on retinal defocus when worn. The power profiles of three commercially available MFCLs were determined. METHODS: Three centre-distance MFCL designs were studied: Biofinity Multifocal D +2.50 add (comfilcon A), Proclear Multifocal D +2.50 add (omafilcon A), and NaturalVue Multifocal (etafilcon A). Two lenses each in power from -1.00D to -6.00D in 1D steps were stored in ISO 18369-3:2017 standard phosphate buffered saline for 24 h. Optical power profiles were measured in a wet cell with the SHSOphthalmic profiler accounting for centre thickness and manufacturer-reported material refractive index. Sagittal power maps from the SHSOphthalmic were exported, and custom MATLAB code was used to generate power profiles by averaging along the vertical and horizontal meridians. One-way anova with Tukey's HSD post-hoc t-tests were used to analyse maximum add power by lens design. RESULTS: Plus power increased out from the lens centre for all three MFCLs. Power profiles of Biofinity D and Proclear D MFCLs show three distinct areas within the optic zone; the distance zone (from lens centre to about 1.6 mm radius), intermediate zone (about 1.6 mm radius to 2.1 mm) and near zone (about 2 mm radius to 4 mm). For NaturalVue MFCLs, plus power starts increasing almost immediately from the lens centre, reaching maximum measured mean plus power at a radius of 2.7 mm. From 2.7 mm to 3.0 mm, there was a decrease in plus power, which was then generally maintained out to the optic zone edge. Across all lens powers, maximum add power was highest with the NaturalVue MFCL (+3.32 ± 0.44D), then Proclear D (+1.84 ± 0.28D) and Biofinity D (+1.47 ± 0.34D) MFCLs (all p < 0.04). Add power peaked at different locations for different lens powers and designs. CONCLUSIONS: Power profiles of MFCLs vary based on lens design and power. These power profiles are consistent with reported myopic and hyperopic changes in peripheral refraction with MFCLs and provide some explanation for reported differences in peripheral refraction with these MFCLs. Further work is needed to determine whether these power profile differences influence myopia progression.

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.

A Randomized Trial to Evaluate the Effect of Toric Versus Spherical Contact Lenses on Vision and Eyestrain.

OBJECTIVES: To compare the effect of toric versus spherical soft contact lenses on objective measures of visual performance using visual acuity and electromyography of the orbicularis oculi muscle. METHODS: Current soft contact lens wearers with -0.75 to -1.75 D astigmatism in each eye were binocularly fitted with toric (1-Day ACUVUE MOIST for astigmatism) and spherical (1-Day ACUVUE MOIST) contact lenses in random order. After each fitting and at 1-week follow-up, high- and low-contrast visual acuities were measured. Electromyography was used to objectively evaluate eyestrain. Linear mixed models were used to assess differences between toric and spherical contact lenses. RESULTS: The mean age (±SD) of the 60 participants was 27.5±5.0 years, spherical refractive error was -3.68±2.01 D, and cylinder was -1.28±0.36 D. High- and low-contrast visual acuities with toric lenses were better than with spherical lenses at both fitting (toric high-contrast: -0.065±0.078 and low-contrast: 0.133±0.103 vs. spherical high-contrast: 0.001±0.104 and low-contrast: 0.224±0.107) and follow-up (toric high-contrast: -0.083±0.087 and low-contrast: 0.108±0.107 vs. spherical high-contrast: -0.015±0.095 and low-contrast: 0.211±0.104) (all P<0.0001). Electromyography-measured eyestrain was less with toric versus spherical contact lenses at fitting (least-square ratio of toric over spherical=0.72; P=0.0019) but not at follow-up (ratio=0.86; P=0.11). CONCLUSION: These results suggest that toric contact lenses provided improved objective measures of vision in a low-to-moderate astigmatic population.

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.

Efficacy of Toric Contact Lenses in Fitting and Patient-Reported Outcomes in Contact Lens Wearers.

OBJECTIVES: To assess whether patient-reported measures are improved with soft toric contact lenses (TCLs) compared with soft spherical contact lenses (SCLs) and whether clinical time needed to fit TCL is greater than SCL. METHODS: Habitual contact lens wearers with vertexed spherical refraction +4.00 to +0.25 D or -0.50 to -9.00 D and cylinder -0.75 to -1.75 DC were randomly assigned to be binocularly fitted into a TCL or SCL, and masked to treatment assignment. Time to successful fit was recorded. After 5 days, the National Eye Institute Refractive Error Quality of Life Instrument (NEI-RQL-42) and modified Convergence Insufficiency Symptom Survey (CISS) were completed. After washout, subjects were fit into the alternative lens design (TCL or SCL). Outcomes were evaluated using linear mixed models for the time to fit and CISS score, generalized linear model for the successful fit, and Wilcoxon tests for the NEI-RQL-42. RESULTS: Sixty subjects (71.7% women, mean age [±SD] = 27.5±5.0 years) completed the study. The mean time to fit the TCL was 10.2±4.3 and 9.0±6.5 min for the SCL (least square [LS] mean difference (TCL-SCL)=1.2, P=0.22). Toric contact lens scored better than SCL in global NEI-RQL-42 score (P=0.006) and the clarity of vision (P=0.006) and satisfaction with correction subscales (P=0.006). CISS showed a 15% reduction in symptoms (LS mean difference [TCL-SCL]=-2.20, P=0.02). CONCLUSION: TCLs are a good option when trying to improve the vision of patients with low-to-moderate astigmatism given the subjective improvements in outcomes.

Aberrometry Repeatability and Agreement with Autorefraction.

SIGNIFICANCE: Commercially available aberrometers are essential to clinical studies evaluating refractive error and image quality. The Discovery System (Innovative Visual Systems, Elmhurst, IL) is a promising clinical instrument that allows investigators to export aberration data for research and analysis purposes. An assessment of the Discovery System's performance is essential to the interpretation of the data obtained. PURPOSE: The aims of this study were to determine the between-visit repeatability of refractive error and higher-order aberration measurements with the Discovery System and to examine between-instrument agreement of refractive error measurements with the Discovery System and Grand Seiko WAM-5500 open-field autorefractor (Grand Seiko Co., Hiroshima, Japan). METHODS: Cycloplegic refractive error values from the Discovery System (over a 3-mm pupil) and the Grand Seiko autorefractor were converted to power vectors (M, J0, and J45), and averaged. Zernike coefficients were also calculated by the Discovery System over a 6-mm pupil through the sixth radial order. Between-visit repeatability and agreement were evaluated using Bland-Altman difference-versus-mean plots. A t-test compared each mean difference (bias) to zero, and the 95% limits of agreement were calculated. RESULTS: Twenty-five young adults with a mean (±SD) cycloplegic spherical-equivalent refractive error of -2.91 ± 1.85 diopters (D) (range, -6.96 to +0.74 D) were enrolled. There were no significant between-visit differences with the Discovery System for M, J0, J45, third- through sixth-order root mean square (RMS), higher-order RMS, or spherical aberration (all P > .30), and the repeatability for defocus and higher-order RMS were ±0.31 D and ±0.095 µm, respectively, for a 6-mm pupil. At a 3-mm pupil, the Discovery System, on average, measured slightly more positive values than the Grand Seiko for M (0.28 D), J0 (0.11 D), and J45 (0.12 D; all P < .005). CONCLUSIONS: The Discovery System was very repeatable and would be an appropriate instrument to measure cycloplegic refractive error and higher-order aberration changes in adults. Small differences in refractive error were found between the Discovery System and Grand Seiko.

Spherical Soft Contact Lens Designs and Peripheral Defocus in Myopic Eyes.

PURPOSE: Peripheral retinal defocus has been implicated in myopia progression. The effect of commercially available spherical soft contact lenses (SCLs) on peripheral defocus of adult myopic eyes was investigated. METHODS: Twenty-five young adults with spherical equivalent (SE) refractions between -0.50D and -6.00D were enrolled. Cycloplegic autorefraction (right eye) was measured centrally and ±20°, ±30°, and ±40° from the line of sight along the horizontal meridian using an autorefractor. Four commercially available spherical SCLs (Biofinity, Acuvue2, PureVision2, and Air Optix Night & Day Aqua) were evaluated. SE defocus (M) was used to calculate relative peripheral defocus (RPD) while wearing each SCL and relative peripheral refraction of the uncorrected eye. Spherical aberration (SA) changes caused by each SCL were measured along the line of sight by aberrometry. Peripheral defocus was analyzed using repeated-measures analyses of variance (RM-ANOVA). The association between changes in axial SA and the change in peripheral defocus was evaluated using linear mixed models. RESULTS: The mean age (±SD) and central SE refractive error were 24.0 ± 1.3 years and -3.45 ± 1.42D, respectively. PureVision2 did not change RPD (P = .33). Significant myopic shifts on the temporal retina were found with three lenses: Acuvue 2 (-0.29D at 30°; -0.80D at 40°; both P ≤ .01), Biofinity (-1.21 D at 40°; P = .02), and Air Optix Night & Day Aqua (-0.23D at 20°, -0.48D at 30°, and -1.50D at 40°; all P < .004). All SCLs caused a negative change in SA. SCLs inducing less negative (more positive) SA changes were associated with a less hyperopic change in RPD. CONCLUSIONS: Spherical SCL design can influence the peripheral defocus profile experienced by a myopic eye. Several, but not all, SCLs reduced peripheral hyperopia. Differences in how SCL types influence peripheral defocus may have implications for myopia progression.

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.

Validation of Macular Choroidal Thickness Measurements from Automated SD-OCT Image Segmentation.

PURPOSE: Spectral domain optical coherence tomography (SD-OCT) imaging permits in vivo visualization of the choroid with micron-level resolution over wide areas and is of interest for studies of ocular growth and myopia control. We evaluated the speed, repeatability, and accuracy of a new image segmentation method to quantify choroid thickness compared to manual segmentation. METHODS: Two macular volumetric scans (25 × 30°) were taken from 30 eyes of 30 young adult subjects in two sessions, 1 hour apart. A single rater manually delineated choroid thickness as the distance between Bruch's membrane and sclera across three B-scans (foveal, inferior, and superior-most scan locations). Manual segmentation was compared to an automated method based on graph theory, dynamic programming, and wavelet-based texture analysis. Segmentation performance comparisons included processing speed, choroid thickness measurements across the foveal horizontal midline, and measurement repeatability (95% limits of agreement (LoA)). RESULTS: Subjects were healthy young adults (n = 30; 24 ± 2 years; mean ± SD; 63% female) with spherical equivalent refractive error of -3.46 ± 2.69D (range: +2.62 to -8.50D). Manual segmentation took 200 times longer than automated segmentation (780 vs. 4 seconds). Mean choroid thickness at the foveal center was 263 ± 24 µm (manual) and 259 ± 23 µm (automated), and this difference was not significant (p = 0.10). Regional segmentation errors across the foveal horizontal midline (±15°) were ≤9 µm (median) except for nasal-most regions closest to the nasal peripapillary margin-15 degrees (19 µm) and 12 degrees (16 µm) from the foveal center. Repeatability of choroidal thickness measurements had similar repeatability between segmentation methods (manual LoA: ±15 µm; automated LoA: ±14 µm). CONCLUSIONS: Automated segmentation of SD-OCT data by graph theory and dynamic programming is a fast, accurate, and reliable method to delineate the choroid. This approach will facilitate longitudinal studies evaluating changes in choroid thickness in response to novel optical corrections and in ocular disease.

Microbial Contamination of Contact Lens Storage Cases During Daily Wear Use.

PURPOSE: To evaluate contact lens (CL) storage case contamination when used with four different CL care solutions during daily wear of three different CL materials. METHODS: A parallel, prospective, bilateral, randomized clinical trial (n = 38) was conducted. Subjects were randomly assigned to use one of three CL materials (etafilcon A, senofilcon A, or galyfilcon A) on a daily wear basis. Subsequently, each subject randomly used one of four different CL care solutions (Biotrue, OPTI-FREE PureMoist, RevitaLens OcuTec, and CLEAR CARE) for 2 weeks, along with their respective storage cases. After every 2-week period, their storage cases were collected and the right and left wells of each storage case were randomized for two procedures: (1) microbial enumeration by swabbing the storage case surface and (2) evaluation of biofilm formation (multipurpose solution cases only) using a crystal violet staining assay. RESULTS: More than 80% of storage cases were contaminated when used in conjunction with the four CL care solutions, irrespective of the CL material worn. Storage cases maintained with CLEAR CARE (mean Log colony forming units (CFU)/well ± SD, 2.0 ± 1.0) revealed significantly (p < 0.001) greater levels of contamination, compared to those maintained with Biotrue (1.3 ± 0.8) and RevitaLens OcuTec (1.2 ± 0.8). Predominantly, storage cases were contaminated with Gram-positive bacteria (≥80%). There were significant differences (p = 0.013) for the levels of Gram-negative bacteria recovered from the storage cases maintained with different CL care solutions. Storage cases maintained with OPTI-FREE PureMoist (0.526 ± 0.629) showed significantly higher biofilm formation (p = 0.028) compared to those maintained with Biotrue (0.263 ± 0.197). CONCLUSIONS: Levels of contamination ranged from 0 to 6.4 Log CFU/storage case well, which varied significantly (p < 0.001) between different CL care solutions, and storage case contamination was not modulated by CL materials.

Eyelid Margin and Meibomian Gland Characteristics and Symptoms in Lens Wearers.

PURPOSE: To describe the lid margin characteristics of contact lens wearers and relate them to comfort during lens wear. METHODS: Three study sites enrolled habitual contact lens wearers. Subjects completed the Comfort domain of the Contact Lens User Experience (CLUE) questionnaire, and each eye was graded for the presence of mucocutaneous junction (MCJ) displacement, lid margin irregularity, and lid margin vascularity. Examiners counted the number of meibomian gland (MG) orifices in the central centimeter of the lower eyelid and the number of those that showed pouting/plugging and vascular invasion. MG expressibility was graded according to the Shimazaki schema. Subjects were grouped based on presence/absence of each characteristic, total number of orifices (≥5 vs. <5), and expressibility (grade 0 vs. >0). Descriptive statistics are reported. A linear model was used to assess the fixed effect of each characteristic on combined CLUE score and each CLUE statement, if the effect on combined CLUE score showed p < 0.10. RESULTS: The study included 203 subjects (67.5% female) with mean age (±SD) of 30.3 ± 9.6 years. The most commonly observed characteristics were orifice pouting/plugging, compromised MG expressibility, and lid margin vascularity (35.0, 30.3, and 20.4%, respectively). MCJ displacement and MG expressibility had an effect on the combined CLUE score such that individual CLUE statements were analyzed (p = 0.01 and p = 0.06, respectively). MCJ displacement had an effect on comfort upon insertion (p = 0.01), comfort after 5 minutes (p = 0.03), end-of-day comfort (p = 0.01), and ability to maintain ocular moisture (p = 0.030). MG expressibility had a significant effect on general comfort (p = 0.01), comfort throughout the day (p = 0.02), and the ability to maintain ocular moisture (p = 0.02). CONCLUSIONS: MCJ displacement and MG expressibility have an effect on contact lens comfort.