Retrospective Analysis of a Clinical Algorithm for Managing Childhood Myopia Progression.

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.

Reduction of Myopic Progression Using a Multifocal Soft Contact Lens: A Retrospective Cohort Study.

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.

Case Series Analysis of Myopic Progression Control With a Unique Extended Depth of Focus Multifocal Contact Lens.

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.

Inhibition of defocus-induced myopia in chickens.

PURPOSE: To 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. METHODS: Eighty-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. RESULTS: On 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. CONCLUSIONS: Use 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.

Myopia progression during three years of soft contact lens wear.

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 = 0.218) and subject age (F = 131.2, p < 0.001, R = 0.319) but not baseline refractive error (F = 2.56, p = 0.11, R = 0.009). The model's overall R 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.

Improving contact-lens related dryness symptoms with silicone hydrogel lenses.

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.

Performance of Lotrafilcon B silicone hydrogel contact lenses in experienced low-Dk/t daily lens wearers.

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.

The stability of dryness symptoms after refitting with silicone hydrogel contact lenses over 3 years.

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.

Inflammatory and mechanical complications associated with 3 years of up to 30 nights of continuous wear of lotrafilcon A silicone hydrogel lenses.

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.

Does the level of available oxygen impact comfort in contact lens wear?: A review of the literature.

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.

Long-term clinical results: 3 years of up to 30-night continuous wear of lotrafilcon A silicone hydrogel and daily wear of low-Dk/t hydrogel lenses.

PURPOSE: To summarize results of a 3-year clinical trial assessing subjective and objective experience with lotrafilcon A silicone hydrogel (SH) lenses for up to 30 nights of continuous wear or low-Dk/t daily-wear (LDW) hydrogel lenses. METHODS: Nineteen sites dispensed SH lenses to 317 subjects (286 current wearers and 31 new wearers) and 2-week replacement LDW lenses to 81 new wearers in a 3-year study. RESULTS: For the SH cohort, limbal redness, conjunctival redness, and corneal neovascularization improved among 23%, 21%, and 13% of eyes, respectively (P<0.001), with no signs increasing significantly. For the LDW cohort, limbal redness, papillary conjunctivitis, and corneal staining increased among 11%, 21%, and 13% of eyes, respectively (P<0.02), with no signs improving significantly. The change in average spherical equivalent power was -0.03 diopters for the age-matched SH cohort and -0.40 diopters for the LDW cohort (P=0.007). During the 3 years, the SH group reported significantly less frequent dryness during and at the end of the day, redness, photophobia, lens awareness, and blurred vision. Significantly more LDW lens wearers reported frequent during-the-day and end-of-day dryness and blurred vision. CONCLUSIONS: During the 3 years, lotrafilcon A lens wearers who wore their lenses continuously for up to 30 nights showed stable, long-term improvements in many signs of corneal health and symptoms along with less myopic progression versus daily wearers of low-Dk/t hydrogel lenses. Many biomicroscopy signs and symptoms worsened among neophytes wearing daily-wear low-Dk/t hydrogel lenses. The use of lotrafilcon A lenses may minimize many ocular changes from soft contact lens wear.

Predictive factors for corneal infiltrates with continuous wear of silicone hydrogel contact 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 and P = .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%).

Impact of previous extended and daily wear schedules on signs and symptoms with high Dk lotrafilcon A lenses.

PURPOSE: This study measured the impact of previous contact lens wearing schedule on the resolution of signs and contact lens-related symptoms among wearers of lotrafilcon A lenses. METHODS: One hundred forty adapted low Dk daily wear (DW) and 140 adapted low Dk extended wear (EW) subjects were enrolled and examined for 1 year (overall study length is 3 years). All subjects wore lotrafilcon A lenses on a wearing schedule of up to 30 nights continuous wear with monthly replacement of lenses. Examinations were conducted at 1 week, 1, 6, and 12 months. RESULTS: The former EW wearers presented at baseline with significantly higher conjunctival staining and epithelial microcysts (p < 0.05) and lower ocular surface symptoms of end of day dryness than the former DW wearers. There were no significant differences in other ocular signs at baseline for the former DW and EW wearers. After use of lotrafilcon A, clinical signs of limbal, conjunctival redness, and neovascularization were significantly better by the 1-week visit for both groups of wearers. Regardless of former wearing schedule, symptoms of dryness (during and at the end of the day) and photophobia were significantly better after 1 week of lotrafilcon A use. The frequency and severity of symptoms of dryness during the day improved significantly among former low Dk DW and EW wearers within 1 week as did severity of dryness during the day for the former DW wearers, in part as a result of their higher prevalence at baseline in the DW group. Subjects reported redness improved significantly by the 1-month visit. CONCLUSIONS: Continuous wear of high Dk silicone hydrogel lenses resulted in an improvement in ocular redness and neovascularization and dryness symptoms among subjects in this trial, regardless of their previous low Dk lens-wearing schedule. All improvements in signs and symptoms were sustained through 12 months.