ABSTRACT SIGNIFICANCE As the myopia epidemic unfolds, there is growing urgency to identify and implement effective interventions to slow myopia progression. This investigation evaluated the effectiveness of an evidence-based myopia treatment algorithm in a clinical setting among 342 consecutive children. PURPOSE This study aimed to evaluate effectiveness of a clinical treatment algorithm for myopia progression in children. METHODS A retrospective cohort analysis was performed using data from myopic children treated for at least 1 year with a defined treatment algorithm incorporating orthokeratology, multifocal lenses, and atropine. The main outcome measures were the percentage of children experiencing ≤0.25 D of myopic cycloplegic spherical equivalent autorefraction (CSER) progression and ≤0.10 mm of axial elongation at 1, 2, and 3 years. The secondary outcome measures were the cumulative absolute reduction of axial elongation values derived from age- and ethnicity-matched virtual control data at 1, 2, and 3 years. RESULTS Mean annual CSER change values (excluding orthokeratology) were −0.30, −0.20, and −0.13 D at 1, 2, and 3 years, respectively, with 59, 56, and 60% of patients demonstrating ≤0.25 D of change over the prior year. Mean annual axial elongation values were 0.13, 0.12, and 0.09 mm at 1, 2, and 3 years, respectively, with 52, 46, and 65% of patients demonstrating ≤0.10 mm of change over the prior year. The cumulative absolute reduction of axial elongation values were 0.11, 0.20, and 0.29 mm for 1, 2, and 3 years, respectively. CONCLUSIONS The treatment algorithm demonstrated effective control of CSER and axial length in a diverse group of progressive myopic children, supporting its use for the clinical management of childhood myopia.

Purpose: To evaluate myopia progression over an approximately 6-year follow-up period in children and young adults wearing a commercially available, daily disposable, soft multifocal contact lens with an extended depth of focus (center distance) design. Methods: This retrospective cohort analysis included data from 196 patients of mean (SD) age 12.3 (2.7) years (range, 5-20 years), fit with the NaturalVue Multifocal (NVMF) contact lens at 15 practices in the United States over 6 years. All patients showed at least -0.50D of myopic progression in at least one eye prior to wearing the lens. Data from the right eye were analyzed. One-way ANOVA with Tukeys post-hoc t-tests were used for statistical analysis, with a significance level set at P < 0.05. Results: After wearing these lenses for 6-72 months, the average myopia progression slowed by approximately 0.84 D or 85% compared to baseline, which was statistically significant at all time points (P < 0.0001). Frequency distribution revealed that 91% of wearers showed a decrease in myopia progression compared to baseline, with 79% of wearers showing a >= 70% reduction in myopia progression. The average change in axial length in a subset of the population over 47 months of follow-up was approximately 0.10 mm/year. Compared with changes expected in an age-and ethnicity-matched myopic virtual control group obtained from published meta-analysis data, both myopic refractive error progression and axial elongation were significantly lower in NVMF wearers at 12, 24 and 36 months (P < 0.001). Analysis of the age-and ethnicity-matched virtual control group predicted that the Cumulative Absolute Reduction of axial Elongation (CARE) value over 3 years would be 0.45 mm. Conclusion: Wearers of the soft multifocal contact lens displayed significant reductions in myopia progression throughout a follow-up period of 6 years.

Purpose: To determine the amount of myopic progression over time with the NaturalVue Multifocal 1 Day Contact Lenses (NVMF), an extended depth of focus design, in clinical practice based on change in refractive error (RE) and axial length (AL) progression over time.

The IOLMaster (Carl Zeiss Meditec AG) is often used for tracking changes in axial length (AL) in myopic progression. The number of measurements for AL values reported in the literature varies from 3 to 20. We performed a prospective analysis to determine the fewest number of measurements to obtain a measurement error (ME) of ≤ 0.04mm and 95% Confidence Interval (CI) of ≤ 0.04mm, or approximately 0.125 Diopters (D). Purpose

Purpose: To evaluate the performance of a novel extended depth of focus multifocal contact lens design for clear vision at distance, intermediate and near visual tasks.

Objectives: To determine the rate of myopia progression in children fit with a commercially available extended depth of focus (center distance) multifocal soft contact lens with attributes theoretically expected to slow the progression of myopia. Methods: A retrospective case series analysis of 32 patients (ages 6–19 years, mean 10.98±2.95) from 10 practice locations was performed. At initial presentation, 44% wore spectacles, 37.5% spherical soft contact lenses, 15.6% a different soft multifocal contact lens, and 3% orthokeratology lenses. All participants showed progression of at least −0.50 diopter with current corrections and were fit with an extended depth of focus (center distance) multifocal soft contact lens (NaturalVue Multifocal 1 Day Contact Lenses; Visioneering Technologies, Inc., Alpharetta, GA). Follow-up time was 6 to 25 months (mean: 10.94±4.76). Results: Reductions in the annualized rate of myopic progression from −0.85 D per year ±0.43 D to −0.04 D per year ±0.18 D (P<0.00000) OD, −0.90 D per year ±0.57 D to −0.03 D per year ±0.17 D (P<0.00000) OS were observed. These data represent a reduction of 95.4% OD and 96.25% OS. Approximately 98.4% of the children showed reduction of annualized myopic progression; 91% showed a decrease of 70% or greater. Overall, 81.25% showed complete halting of myopic progression, including 6.25% demonstrating myopic regression. Conclusions: This unique extended depth of focus (center distance) daily disposable multifocal contact lens was effective in slowing myopic progression in these children. These findings add to the growing evidence that center distance multifocal soft contact lenses may slow the progression of myopia.

Program Number: 3615 Poster Board Number: A0064 Presentation Time: 3:45 PM–5:30 PM Prevalence and characteristics of myopic retinopathy in an adult Chinese American population: The Chinese American Eye Study Rohit Varma1, Stacy M. Meuer2, Ronald Klein2, Shuang Wu1. 1Ophthalmology & Visual Sciences, Illinois Eye & Ear Infirmary, Chicago, IL; 2Ophthalmology and Visual Sciences, University of Wisconsin at Madison, Madison, WI. Purpose: To provide estimates of the prevalence and characteristics of myopic retinopathy in a population based sample of adult Chinese Americans. Methods: The Chinese-American Eye Study (CHES) is a populationbased study in which Chinese-Americans aged 50 years and older residing in 10 contiguous census tract in Monterey Park, CA were invited to undergo a comprehensive eye exam, including subjective and objective refraction, stereoscopic fundus photography of both eyes. Myopic retinopathy was assessed in a masked manner by trained graders. Specifically, myopic retinopathy was defined as the presence of one or more of the following lesions staphyloma, lacquer cracks, patchy or diffused atrophy, intrachoroidal cavitation, tilted optic disc, tessellation, peripapillary atrophy and exudative myopia. Eyes with spherical equivalent ≤ -0.5 diopters and/or with axial length ≥ 24mm were evaluated for myopic retinopathy. One eye (eye with the more myopic refractive error) from each participant was included in this analysis. Frequency distributions stratified by refractive error and axial length were calculated. Differences were assessed using chi square testing. Results: Of the 1,590 participants meeting the selection criteria and with gradable fundus photographs, 1,328 participants were graded for myopic retinopathy. The overall prevalence of myopic retinopathy among eyes was 33.7% (95%CI 31.2%-36.2%). The prevalence of specific lesions were Tessellation (32.4%), tilted disc (29.8%), peripapillary atrophy (8.2%), staphyloma (6.3%), diffused atrophy (5.0%), lacquer cracks (2.9%), intrachoroidal cavitation (2.4%), patchy atrophy (1.1%), and exudative myopia (0.2%).The prevalence of myopic retinal changes in persons with mild (≤ -0.5D, > -1D), moderate (≤ -1D, > -6D) and high myopia (≤ -6D) were 17%, 46% and 83% respectively. The prevalence of myopic retinal changes in persons with varying degrees of axial elongation were: <23mm – 11%, ≥ 23.0, <24.5mm – 26%, ≥ 24.5, <26mm – 56%, ≥26mm – 82%. No ageor gender-related differences were observed. Conclusions: These data provide the first population-based estimates of myopic retinopathy in Chinese Americans. The prevalence of myopic retinopathy in Chinese Americans is higher than that observed in other East Asian populations. Commercial Relationships: Rohit Varma, None; Stacy M. Meuer, None; Ronald Klein, None; Shuang Wu, None Support: NIH Grant EY-017337 and Research to Prevent Blindness, NY Program Number: 3616 Poster Board Number: A0065 Presentation Time: 3:45 PM–5:30 PM Retinal pathology in highly myopic eyes: ZOC-BHVI High Myopia Study linxing chen1, Brien A. Holden2, Mingguang He1. 1Zhongshan Ophthalmic Center, Guangzhou, China; 2Brien Holden Vision Institute, Sydney, ACT, Australia. Purpose: High myopia is a major cause of blindness and vision impairment. This study was initiated to evaluate the occurrence of retinal pathology in highly myopic eyes and its impact on visual impairment. Methods: Nine hundred and seventeen participants aged between 7 to 70 years with myopia ≥ -6.00 D in both eyes were recruited from the Zhongshan Ophthalmic Centre clinic for this ZOC-BHVI High Myopia Study. The mean age of participants was 22.1 ± 12.5 years. Exclusion criteria included any systemic or ocular conditions including syndromic high myopia, previous ocular surgery, optical or therapeutic treatment for myopia. Ocular parameters measured in both eyes were: cycloplegic autorefraction, subjective refraction, best corrected visual acuity (BCVA), and axial length (AL) using partial coherence interferometry. Retinal findings were confirmed by slit lamp fundus examination, using 3-mirror fundus lens, and recorded as A. normal; B. abnormal (categories: a. retinal break; b. macular oedema; c. posterior staphyloma; d. retinal detachment). Vision was classified as: Normal Vision (≥ 1.0); Mild Vision Impairment (<1.0 to <0.3); Moderate Vision Impairment (0.3 to ≥0.1); Severe Visual Impairment (<0.1 to ≥0.05) and Blindness (<0.05). Proportion of retinal pathology among the eyes by the categories of age group, spherical equivalent and axial length was calculated. Results: Data from 1686 eyes (843 participants; 442 female) were analysed. The mean spherical equivalent (SE) was -9.30 ± 2.9 D (range: -6.00 to -29.80 D); axial length 27.2 mm ± 1.4 (range 23.8 to 31.8 mm). Myopic retinal pathology was seen in 13.3% (224 eyes). The prevalence of retinal pathology ranged from 5% for age <15 years to 51% for those up to 55 years; 6% for ALs up to 24 mm up to 54% for 32 mm; 5% for -6 D of myopia to up to 65% for -39 D (see Figure1). Proportions of vision impairment among the eyes with retinal pathology were: no VI, 57.0%; mild VI, 40.4%; moderate VI, 2.3% and 0.4% were blind. Multiple logistic regression with robust estimation of variance indicated that age and axial length were the most powerful associates for retinal pathology Conclusions: The prevalence of retinal pathology increases with increasing age, axial length and refractive error. Retinal pathology may be present in eyes with high myopia even when there is no, or only mild vision impairment Commercial Relationships: linxing chen, None; Brien A. Holden, None; Mingguang He, None Support: Australian Government Cooperative Research Centres Grant Scheme

PURPOSETo determine the effect of wearing a lens with a unique peripheral optical design on the development and progression of defocus-induced myopia in newly hatched chickens.METHODSEighty-five newly hatched chickens underwent bilateral retinoscopy and A-scan ultrasound to determine their refractive error and axial length. They were randomly divided into Control and two Test groups, in which each chicken was fitted with a goggle-lens over the right eye, with the left eye remaining untreated. The Control group wore a lens of power -10.00 diopters (D) of standard spherical optical design. The two Test lenses both had a central optical power -10.00 D, but used different peripheral myopia progression control (MPC) designs. For all groups, retinoscopy was repeated on days 3, 7, 10, and 14; ultrasound was repeated on day 14.RESULTSOn day 0 there was no statistical difference in refractive error (mean +6.92 D) or axial length (mean 8.06 mm) between Test and Control groups or treated and untreated eyes (all P 0.05). At day 14, 37 (43.5%) of 85 chickens had not experienced goggle detachment and were included in the final analyses. in this cohort there was a significant refractive difference between the treated eyes of the control group (n = 17) and those of test 1 (n = 14) and Test 2 (N = 6) groups (both P <0.01): Control -4.65 ± 2.11 D, Test 1 +4.57 ± 3.11 D, Test 2 +1.08 ± 1.24 D (mean ± SEM). There was also a significant axial length difference (both P < 0.01): Control 10.55 ± 0.36 mm, Test 1 9.99 ± 0.14 mm, Test 2 10.17 ± 0.18 mm.CONCLUSIONSUse of these unique MPC lens designs over 14 days caused a significant reduction in the development of defocus-induced myopia in chickens; the degree of reduction appeared to be design specific.

Purpose. To analyze the effect of lens material alone on myopia progression in a multi-center non-randomized prospective study of daily wear hydrogel and continuous wear silicone hydrogel contact lenses.Methods. Refractive error data from completing subjects were collected during a 3-year study of 54 subjects wearing low-Dk/t hydrogel contact lenses for daily wear and 230 wearing silicone hydrogel contact lenses for up to 30 nights continuous wear. Univariate analysis of refractive error changes was first conducted on factors of lens type, age at baseline, and baseline refractive error. Multivariate analysis was then performed to control for potential confounders of age (categorical by decade and continuous), and baseline refractive error.Results. Multivariate analysis showed that refractive error changes were significantly affected by lens type (F = 78.2, p < 0.001, R-2 = 0.218) and subject age (F = 131.2, p < 0.001, R-2 = 0.319) but not baseline refractive error (F = 2.56, p = 0.11, R-2 = 0.009). The model's overall R-2 value is 0.376; the age-adjusted refractive error changes are +0.02 D for the silicone hydrogel contact lens wearers and -0.41 D for the hydrogel contact lenses for the 3-year follow-up period.Conclusions. Subject age and lens type significantly influenced the degree of myopic progression, with younger subjects and low-Dk/t hydrogel contact lens wearers increasing more during the study. The Lotrafilcon A silicone hydrogel lens material may contribute to less myopia progression in adult contact lens wearers. (Optom Vis Sci 2009;86:1150-1153)

Purpose. To determine dryness symptoms attributable to hydrogel contact lens (HCL) wear by comparing symptoms from age-matched HCL wearers and non-wearers in a cross-sectional study, and to compare that difference to the change in proportion of subjects reporting frequent dryness among HCL wearers after refitting with lotrafilcon A or B silicone hydrogels (SHCLs). Methods. Prevalence of frequent dryness symptoms was compared between HCL and non-wearers from a cross-sectional, historical dataset of Dry Eye/Contact Lens Dry Eye Questionnaires using an age-matched subset of 259 HCL and 246 non-wearers. Prospective change in prevalence of frequent dryness from non-randomized studies (n = 1036), in which daily wear (DW) HCL wearers were refit with lotrafilcon A or B SHCLs, was then compared to the cross-sectional difference between HCL wearers and non-wearers. Results. In the Dry Eye/Contact Lens Dry Eye Questionnaires dataset, 47% fewer non-wearers reported frequent dryness than HCL wearers (p = 0.0001). In the lotrafilcon A DW refitting trials, frequent dryness was reported by 67 and 62% fewer subjects for during the day (DD) and end of the day (EOD) dryness (p = 0.0001, both) after refitting. In continuous wear lotrafilcon A trials, there were 63 and 41% reductions in the proportion reporting frequent DD and EOD dryness (p = 0.014 and p = 0.02). Refitting to DW lotrafilcon B yielded a 48 and 46% reduction in the number of subjects reporting frequent DD and EOD dryness (p < 0.0001, both). Conclusions. After refitting DW HCL wearers with either lotrafilcon A or B SHCLs, the proportion of symptomatic wearers was approximately half; an amount similar to the difference in proportion between HCL and non-wearers. This raises the possibility that refitting HCL wearers with SHCLs eliminates the component of dryness that is induced by HCL wear. Further research with more robust experimental design is recommended to test this hypothesis.

PURPOSE:Wear of low-Dk/t lenses has long been associated with signs and symptoms indicative of hypoxia and with patient symptoms of dryness and discomfort. Although patient discomfort during soft contact lens wear has been generally attributed to lens dehydration, research studies aimed at verifying that connection have been unsuccessful. With the advent of high-Dk/t silicone hydrogel lenses, not only have improvements in clinical signs of hypoxia been documented, but improvements in patient symptoms of dryness and discomfort also have been documented. This literature review was undertaken to examine historic and current literature to determine whether the level of available oxygen is associated with patient symptoms of dryness and discomfort.METHODS:Literature was reviewed related to soft contact lens dehydration, corneal hypoxia, patient symptoms of dryness and discomfort, and current clinical studies of silicone hydrogel lens wear.RESULTS:Through the years, the body of knowledge has grown supporting a connection between decreased levels of available oxygen to the cornea caused by low-Dk/t contact lens wear and negative impacts on the signs of corneal health and patient symptoms.CONCLUSIONS:Available published literature suggests that many of these changes in patient signs and symptoms seen with low-Dk/t lens wear may be related to an inflammatory response. Clinical studies of high-Dk/t silicone hydrogel lenses further support a significant connection between the level of available oxygen during contact lens wear and improved patient symptoms of comfort, including dryness.

Purpose. The silicone hydrogel lens O2OPTIX with a Dk/t of 138 (at –3.00 diopters [D]) was evaluated and compared with patients' habitual low-Dk/t lenses. Methods. This large, multisite (United States and Canada), single-masked study enrolled experienced daily-wear, low-Dk/t, 2-week replacement soft contact lens wearers. Subjects underwent baseline evaluations and were fitted with O2OPTIX lenses for a 2-week period. After 2 weeks, subjects returned for assessment versus their habitual lenses. Results. Data for 760 subjects were analyzed. The overall average habitual contact lens power was –3.13 D, and the average O2OPTIX lens power was –3.22 D. Biomicroscopy evaluations showed improvements in signs related to corneal health with O2OPTIX. Conjunctival and limbal redness, corneal neovascularization, corneal edema, and corneal and conjunctival staining all decreased significantly from baseline. O2OPTIX lenses performed better than habitual lenses in terms of comfort, symptoms, and overall preference. When wearing O2OPTIX lenses, significantly fewer subjects reported problems compared to their habitual lenses, including uncomfortable lens wear (–20.3%), redness (–44.5%), dryness during the day (–40.2%), and dryness at the end of the day (–34.4%); 47.9% reported that they could wear O2OPTIX lenses longer than their habitual lenses. At the end of study, among those with a preference, a significantly greater proportion of patients (60.3%) preferred O2OPTIX lenses to their habitual lenses. Conclusions. Daily wear of O2OPTIX lenses resulted in improvements in corneal signs of health and patient symptoms and provided excellent vision and comfort. O2OPTIX lenses were preferred by subjects over their habitual lenses.

Objective To estimate the cumulative probability and risk factors for developing corneal infiltrates after up to 3 years of continuous wear (CW) with lotrafilcon A lenses. Methods Patients were fitted with lotrafilcon A lenses and followed up for 3 years. The main outcome variable was the first occurrence of any infiltrative event in either eye. Cox proportional hazards regression was used to model the probability of developing infiltrates as a function of demographic and biomicroscopy findings. Results A total of 317 patients participated in this study. The Kaplan-Meier unadjusted cumulative incidence of a corneal infiltrate after CW was 5.7% (95% confidence interval [CI], 3.0%-8.4%) at the end of 1 year, 8.5% (95% CI, 5.2%-11.9%) at the end of 2 years, and 10.3% (95% CI, 6.6%-13.9%) at the end of 3 years. Corneal staining and limbal redness present in the affected eye on a previous visit were significantly associated with the development of an infiltrative event (hazard ratios, 7.23 and 3.18;P<.001 andP = .02, respectively). Conclusions Corneal staining and limbal redness may predict the subsequent development of an infiltrative event among CW contact lens patients. The probability of remaining free of any corneal infiltrates at the end of 3 years of CW of contact lenses was 89.7% (95% CI, 86.1%-93.4%).

PURPOSE:To report the ocular complications occurring during a 3-year clinical trial of subjects wearing lotrafilcon A silicone hydrogel lenses for up to 30 nights of continuous wear.METHODS:Nineteen sites enrolled 317 subjects (286 current wearers and 31 new wearers), who were dispensed lotrafilcon A lenses with 3 years of follow-up.RESULTS:By the 1-month visit, continuous wear of up to 30 nights was recommended for 87% of subjects. The 27 lens-related adverse events included 15 (2.4%) eyes in year 1, seven (1.3%) eyes in year 2, and five (0.8%) eyes in year 3. Lens-related inflammatory events involved 12 (1.9%) eyes in year 1 and five (0.8%) eyes each in years 2 and 3. One third of the inflammatory events occurred in the first 3 months. Mechanical events included two superior epithelial arcuate lesions and one case of bilateral contact lens papillary conjunctivitis in years 1 and 2. No subjects experienced microbial keratitis during the 3-year trial. Two subjects with events discontinued from the trial.CONCLUSIONS:These results show that the rate of contact lens adverse events occurring with lotrafilcon A is low in this cohort, with the highest likelihood occurring during the first 3 months of the study. There was a decrease in the rate of events during the later years of the study. Although clinicians should understand the likelihood of adverse inflammatory and mechanical events and their possible recurrence, the rate of these events may be lower in practice than previously reported.

PURPOSE:To assess the stability of dryness symptoms after refitting patients wearing low-Dk/t hydrogel contact lenses with high-Dk/t silicone hydrogel contact lenses and to determine whether early dryness symptoms were predictive of discontinuation in the 3-year study.METHODS:Two hundred seventy-eight hydrogel lens wearers were refitted with lotrafilcon A silicone hydrogel contact lenses for continuous wear of up to 30 nights. Self-administered questionnaires at baseline, 1 week, and 3 years captured the frequency and intensity of dryness symptoms during the day and at the end of the day. One-week and 3-year responses were compared to baseline by a Bowker test of symmetry and median change in response with Wilcoxon signed rank test.RESULTS:Frequency of during-the-day and end-of-day dryness decreased from baseline to 1 week and 3 years (during the day, frequency > or = "sometimes" 57.1% vs. 33.1% after 1 week and 58.5% vs. 28.8% after 3 years; end of day, 61.1% vs. 41.0% after 1 week and 64.0% vs. 35.9% after 3 years [P<0.0001 for all comparisons]). After refitting, the proportion of subjects with dryness symptoms was stable. After 1 week, the presence of frequency of at least "sometimes" and severity of at least "moderate" during-the-day and end-of-day dryness were significantly associated with study discontinuation (during-the-day frequency [P=0.007] and severity [P=0.017]; end-of-day frequency [P=0.002] and severity [P=0.003]).CONCLUSIONS:Dryness symptoms improved after 1 week of refitting with lotrafilcon A and remained stable through 3 years. The presence of dryness after 1 week was associated with discontinuation from contact lens wear. Refitting with silicone hydrogel lenses reduced the frequency and severity of dryness symptoms seen with hydrogel lens wear for many subjects.