Treatment of severe amblyopia with weekend atropine: results from 2 randomized clinical trials.

PURPOSE: To determine the effectiveness of weekend atropine for severe amblyopia from strabismus, anisometropia, or both combined among children 3 to 12 years of age. METHODS: We enrolled children into 2 prospective, randomized multicenter clinical trials of amblyopia therapy. Herein we report the results for severe amblyopia, 20/125 to 20/400. In Trial 1, 60 children 3 to 6 years of age (mean, 4.4 years) were randomized to weekend atropine plus a plano lens or weekend atropine plus full spectacle correction for the sound eye. In Trial 2, 40 children 7 to 12 years of age (mean, 9.3 years) were randomized to weekend atropine or 2 hours of daily patching. The visual acuity outcome was assessed at 18 weeks in Trial 1 and 17 weeks in Trial 2. RESULTS: In Trial 1, visual acuity improved by an average of 4.5 lines in the atropine plus correction group (95% CI, 3.2-5.8 lines) and 5.1 lines in the atropine plus plano lens group (95% CI, 3.7-6.4 lines). In Trial 2, visual acuity improved by an average of 1.5 lines in the atropine group (95% CI, 0.5-2.5 lines) and 1.8 lines in the patching group (95% CI, 1.1-2.6 lines). CONCLUSIONS: Weekend atropine can improve visual acuity in children 3 to 12 years of age with severe amblyopia. Improvement may be greater in younger children.

Instability of ocular alignment in childhood esotropia.

OBJECTIVE: Instability of ocular alignment may cause surgeons to delay surgical correction of childhood esotropia. The authors investigated the stability of ocular alignment over 18 weeks in children with infantile esotropia (IET), acquired nonaccommodative esotropia (ANAET), or acquired partially accommodative esotropia (APAET). DESIGN: Prospective, observational study. PARTICIPANTS: Two hundred thirty-three children aged 2 months to less than 5 years with IET, ANAET, or APAET of less than 6 months' duration. METHODS: Ocular alignment was measured at baseline and at 6-week intervals for 18 weeks. MAIN OUTCOME MEASURES: Using definitions derived from a nested test-retest study and computer simulation modeling, ocular alignment was classified as unstable if there was a change of 15 prism diopters (PD) or more between any 2 of the 4 measurements, as stable if all 4 measurements were within 5 PD or less of one another, or as uncertain if neither criteria was met. RESULTS: Of those who completed all 3 follow-up visits within time windows for analysis, 27 (46%) of 59 subjects with IET had ocular alignment classified as unstable (95% confidence interval [CI], 33%-59%), 20% as stable (95% CI, 11%-33%), and 34% as uncertain (95% CI, 22%-47%). Thirteen (22%) of 60 subjects with ANAET had ocular alignment classified as unstable (95% CI, 12%-34%), 37% as stable (95% CI, 25%-50%), and 42% as uncertain (95% CI, 29%-55%). Six (15%) of 41 subjects with APAET had ocular alignment classified as unstable (95% CI, 6%-29%), 39% as stable (95% CI, 24%-56%), and 46% as uncertain (95% CI, 31%-63%). For IET, subjects who were older at presentation were less likely to have unstable angles than subjects who were younger at presentation (risk ratio for unstable vs stable per additional month of age, 0.85; 99% CI, 0.74-0.99). CONCLUSIONS: Ocular alignment instability is common in children with IET, ANAET, and APAET. The impact of this finding on the optimal timing for strabismus surgery in childhood esotropia awaits further study. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Stability of visual acuity improvement following discontinuation of amblyopia treatment in children aged 7 to 12 years.

OBJECTIVE: To assess the stability of visual acuity improvement during the first year after cessation of amblyopia treatment other than spectacle wear in children aged 7 to 12 years. METHODS: At the completion of a multicenter randomized trial during which amblyopia treated with patching and atropine improved by at least 2 lines on the electronic Early Treatment of Diabetic Retinopathy Study testing protocol, 80 patients aged 7 to 12 years were followed up while not receiving treatment (other than spectacle wear) for 1 year. MAIN OUTCOME MEASURE: Ten letters or more (> or =2 lines) worsening of visual acuity (measured using the electronic Early Treatment of Diabetic Retinopathy Study testing protocol) during the year following treatment discontinuation. RESULTS: During the year following cessation of treatment, the cumulative probability of worsening visual acuity (> or =2 lines) was 7% (95% confidence interval, 3%-17%); 82% of patients maintained an increase in visual acuity of 10 letters or more compared with their visual acuity before starting treatment. CONCLUSION: Visual acuity improvement occurring during amblyopia treatment is sustained in most children aged 7 to 12 years for at least 1 year after discontinuing treatment other than spectacle wear. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00094692.

A symptom survey and quality of life questionnaire for nasolacrimal duct obstruction in children.

PURPOSE: To develop and validate a new parental questionnaire addressing symptoms and health-related quality of life (HRQL) in childhood nasolacrimal duct obstruction (NLDO). DESIGN: Cross-sectional study. PARTICIPANTS: Children ages 6 to younger than 48 months with and without clinical signs of NLDO. METHODS: A new questionnaire was developed using semistructured interviews with parents of children with NLDO and through discussions with expert clinicians. Questionnaires were completed by parents of children with and without NLDO. Cronbach's alpha was calculated as a measure of internal-consistency reliability. Factor analysis was used to evaluate a priori subscales: symptoms and HRQL. Discriminant construct validity was assessed by comparing questionnaire scores between children with and without NLDO and between affected and unaffected eyes of children with unilateral NLDO. Instrument responsiveness was determined by comparing presurgical and postsurgical intervention scores in a subset of NLDO patients who underwent surgical treatment. MAIN OUTCOME MEASURE: The NLDO questionnaire score. RESULTS: Eighty-seven children were enrolled, 56 with and 31 without NLDO. All but 2 questions on the questionnaire showed a good distribution of responses, a high correlation with the rest of the questionnaire, and excellent discrimination between patients with and without NLDO. Cronbach's alpha values were good for the overall questionnaire (0.95), and for 2 predetermined subscales: symptoms (0.95) and HRQL (0.85). On a 0 to 4 scale, NLDO patients had worse scores compared with non-NLDO patients for both symptoms (mean difference, 2.1; 95% confidence interval [CI], 1.9-2.3) and HRQL (mean difference, 1.2; 95% CI, 0.9-1.5) subscales. The NLDO patients had worse scores before intervention compared with after intervention for both the symptoms (mean difference, 2.2; 95% CI, 1.6-2.9) and HRQL (mean difference, 1.4; 95% CI, 0.8-2.1) subscales. Finally, NLDO patients had worse symptom scores for affected eyes compared with unaffected eyes (mean difference, 2.3; 95% CI, 1.9-2.6). CONCLUSIONS: This novel NLDO questionnaire is useful in quantifying parental perception of symptoms and HRQL in childhood NLDO. The questionnaire may have a role in future clinical studies of NLDO.

A randomized pilot study of near activities versus non-near activities during patching therapy for amblyopia.

BACKGROUND: To plan a future randomized clinical trial, we conducted a pilot study to determine whether children randomized to near or non-near activities would perform prescribed activities. A secondary aim was to obtain a preliminary estimate of the effect of near versus non-near activities on amblyopic eye visual acuity, when combined with 2 hours of daily patching. METHODS: Sixty-four children, 3 to less than 7 years of age, with anisometropic, strabismic, or combined amblyopia (20/40 to 20/400) were randomly assigned to receive either 2 hours of daily patching with near activities or 2 hours of daily patching without near activities. Parents completed daily calendars for 4 weeks recording the activities performed while patched and received a weekly telephone call in which they were asked to describe the activities performed during the previous 2 hours of patching. Visual acuity was assessed at 4 weeks. RESULTS: The children assigned to near visual activities performed more near activities than those assigned to non-near activities (by calendars, mean 1.6 +/- 0.5 hours versus 0.2 +/- 0.2 hours daily, P < 0.001; by telephone interviews, 1.6 +/- 0.4 hours versus 0.4 +/- 0.5 hours daily, P < 0.001). After 4 weeks of treatment, there was a suggestion of greater improvement in amblyopic eye visual acuity in those assigned to near visual activities (mean 2.6 lines versus 1.6 lines, P = 0.07). The treatment group difference in visual acuity was present for patients with severe amblyopia but not moderate amblyopia. CONCLUSIONS: Children patched and instructed to perform near activities for amblyopia spent more time performing those near activities than children who were instructed to perform non-near activities. Our results suggest that performing near activities while patched may be beneficial in treating amblyopia. Based on our data, a formal randomized amblyopia treatment trial of patching with and without near activities is both feasible and desirable.

Isoametropic amblyopia due to high hyperopia in children.

PURPOSE: To identify children with isoametropic amblyopia due to moderate to high hyperopia and evaluate associated findings and visual acuity outcome. METHODS: Charts from two university's pediatric ophthalmology clinics were reviewed retrospectively. Healthy children with > or = +4.5 D spherical equivalent who did not have anisometropia > or = 1.5 D were selected for data collection. The charts of qualifying children with bilateral amblyopia (visual acuity of 20/40 or less) were further analyzed. RESULTS: Identified were 418 children with the above set of criteria for hyperopia; 36 of these children had isoametropic amblyopia (bilateral amblyopia). This gives an estimated prevalence of isoametropic amblyopia of 8.6% in children with at least 4.5 D of hyperopia in one or both eyes. The children with isoametropic amblyopia presented at a later age (5 years, 1 month) than the overall group of hyperopes (3 years, 5 months). Strabismus was less prevalent in this group (64%) than in the entire population of children with high hyperopia (81%). These children's amblyopia responded well to treatment with glasses, and patching in 13 (36%) cases. Surgical intervention for residual strabismus was necessary in very few cases (2 of 36, 5.5%). CONCLUSION: Children with hyperopia > or = 4.5 D have an increased risk of amblyopia and strabismus that further threatens their future visual function. Isoametropic amblyopia is a real risk in these children. Based on these results, hyperopic correction should be prescribed for children with > or = 4.5 D of hyperopia even if no strabismus or fixation preference is detected, to reduce this risk. Screening programs should also be in place to identify these children at an early age.