CLINICAL TRIALS SECTION EDITOR: Randomized Trial of Treatment of Amblyopia in Children Aged 7 to 17 Years Pediatric Eye Disease Investigator Group (original) (raw)
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Randomized Trial of Treatment of Amblyopia in Children Aged 7 to 17 Years
2005
Objective: To evaluate the effectiveness of treatment of amblyopia in children aged 7 to 17 years. Methods: At 49 clinical sites, 507 patients with amblyopic eye visual acuity ranging from 20/40 to 20/400 were provided with optimal optical correction and then randomized to a treatment group (2-6 hours per day of prescribed patching combined with near visual activities for all patients plus atropine sulfate for children aged 7 to 12 years) or an optical correction group (optical correction alone). Patients whose amblyopic eye acuity improved 10 or more letters (Ն2 lines) by 24 weeks were considered responders.
A randomized trial of prescribed patching regimens for treatment of severe amblyopia in children
Ophthalmology, 2003
Objective: To compare full-time patching (all hours or all but 1 hour per day) to 6 hours of patching per day, as prescribed treatments for severe amblyopia in children younger than 7 years. Design: Prospective, randomized multicenter clinical trial (32 sites). Participants: One hundred seventy-five children younger than 7 years with amblyopia in the range of 20/100 to 20/400. Intervention: Randomization either to full-time patching or to 6 hours of patching per day, each combined with at least 1 hour of near-visual activities during patching. Main Outcome Measure: Visual acuity in the amblyopic eye after 4 months. Results: Visual acuity in the amblyopic eye improved a similar amount in both groups. The improvement in the amblyopic eye acuity from baseline to 4 months averaged 4.8 lines in the 6-hour group and 4.7 lines in the full-time group (P ϭ 0.45). Conclusion: Six hours of prescribed daily patching produces an improvement in visual acuity that is of similar magnitude to the improvement produced by prescribed full-time patching in treating severe amblyopia in children 3 to less than 7 years of age.
The Clinical Profile of Moderate Amblyopia in Children Younger Than 7 Years
Archives of Ophthalmology, 2002
To describe the demographic and clinical characteristics of a cohort of children with moderate amblyopia participating in the Amblyopia Treatment Study 1, a randomized trial comparing atropine and patching. Methods: The children enrolled were younger than 7 years and had strabismic, anisometropic, or combined strabismic and anisometropic amblyopia. Visual acuity, measured with a standardized testing protocol using single-surround HOTV optotypes, was 20/40 to 20/100 in the amblyopic eye, with an intereye acuity difference of 3 or more logMAR lines. There were 419 children enrolled, 409 of whom met these criteria and were included in the analyses. The mean age of the 409 children was 5.3 years. The cause of the amblyopia was strabismus in 38%, anisometropia in 37%, and both strabismus and anisometropia in 24%. The mean visual acuity of the amblyopic eyes (ap-proximately 20/60) was similar among the strabismic, anisometropic, and combined groups (P=.24), but visual acuity of the sound eyes was worse in the strabismic group compared with the anisometropic group (PϽ.001). For the patients randomized into the patching group, 43% were initially treated for 6 hours per day, whereas 17% underwent full-time patching. Patients with poorer visual acuity in the amblyopic eye were prescribed more hours of patching than patients with better acuity (P=.003). Conclusions: In the Amblyopia Treatment Study 1, there were nearly equal proportions of patients with strabismic and anisometropic amblyopia. A similar level of visual impairment was found irrespective of the cause of amblyopia. There was considerable variation in treatment practices with regard to the number of hours of initial patching prescribed.
Archives of Ophthalmology, 2007
Objective-To assess the stability of visual acuity improvement during the first year after cessation of amblyopia treatment other than spectacles in 7 to 12 year olds Methods-At the completion of a multi-center randomized trial during which amblyopia treated with both patching and atropine improved by at least 2 lines, 80 patients 7 to 12 years old were followed off treatment (other than spectacles) for one year. Main Outcome Measure-Ten or more letters (2 or more lines) worsening of visual acuity (measured using the electronic ETDRS method) during the year following treatment discontinuation Results-During the year following cessation of treatment, the cumulative probability of worsening acuity (2 or more lines) was 7% (95% confidence interval 3% to 17%); 82% of patients maintained an increase in acuity of 10 or more letters compared with acuity prior to starting treatment. Conclusion-Visual acuity improvement occurring during amblyopia treatment is sustained in most 7 to 12 year olds for at least one year after discontinuing treatment other than spectacles. Application to Clinical Practice-The data support the treatment of 7 to 12 year olds with amblyopia by demonstrating that acuity improvement can be maintained after treatment is discontinued.
Eye patching as a treatment for amblyopia in children aged 10–16 years
Japanese Journal of Ophthalmology, 2011
Purpose To investigate the effects of full-time patching regimen on the treatment of amblyopia in children aged 10-16 years. Methods Forty-seven patients with a mean age of 12.09 ± 1.65 years were included in this study. All of the patients received eye patching for the entire day, 6 days a week, during the first 3 months. The patients who achieved visual acuity of 0.00 logMAR at the third month were provided with additional patching treatment (4-6 h/day). On the other hand, the patients who showed no change in their visual acuity or an increase of less than 0.00 logMAR at the third month had 3 more months of eye patching for the entire day, 6 days a week. Results Prior to treatment, the best mean visual acuity of the amblyopic eyes was 0.48 ± 0.25 (range 1.00-0.15) logMAR. After follow-up, the visual acuity of the amblyopic eyes was 0.20 ± 0.22 (range 1.00-0.00) logMAR. Thus, visual acuity in the amblyopic eyes improved by 0.2 log unit or more in 38 of 47 patients (81%). Conclusions The present results show that patching in older children with amblyopia improves visual acuity with no serious complications. The use of patching in children to improve amblyopia seems promising.
Ophthalmology, 2006
Objective: To compare 2 hours of daily patching (combined with 1 hour of concurrent near visual activities) with a control group of spectacle wear alone (if needed) for treatment of moderate to severe amblyopia in children 3 to 7 years old. Design: Prospective randomized multicenter clinical trial (46 sites). Participants: One hundred eighty children 3 to 7 years old with best-corrected amblyopic-eye visual acuity (VA) of 20/40 to 20/400 associated with strabismus, anisometropia, or both who had worn optimal refractive correction (if needed) for at least 16 weeks or for 2 consecutive visits without improvement. Intervention: Randomization either to 2 hours of daily patching with 1 hour of near visual activities or to spectacles alone (if needed). Patients were continued on the randomized treatment (or no treatment) until no further improvement was noted. Main Outcome Measure: Best-corrected VA in the amblyopic eye after 5 weeks. Results: Improvement in VA of the amblyopic eye from baseline to 5 weeks averaged 1.1 lines in the patching group and 0.5 lines in the control group (P ϭ 0.006), and improvement from baseline to best measured VA at any visit averaged 2.2 lines in the patching group and 1.3 lines in the control group (PϽ0.001). Conclusion: After a period of treatment with spectacles, 2 hours of daily patching combined with 1 hour of near visual activities modestly improves moderate to severe amblyopia in children 3 to 7 years old.
Clinical Profile of Amblyopia Patients Between 5-15 Years of Age
BACKGROUND The aim of the study is to-1. Diagnose strabismic, anisometropic and mixed amblyopia in age group 5-15 years. 2. Analyse these patients for age, sex, type of refractive error, type of squint, type of fixation pattern and classify them aetiologically. 3. Study effectiveness of different amblyopia treatments in this age group. MATERIALS AND METHODS Patients in 5-15 years of age in a period of two years were selected and assessed for amblyopia, which included a detailed history, visual acuity, retinoscopy, ocular movements and alignment, slit lamp examination, fundus examination. Patients were given amblyopia treatment and assessed for improvement. Settings and Design-Hospital-based descriptive study in a period of two years. RESULTS In 32 amblyopic patients, maximum patients were of age group between 5-7 years. 53.12% of patients were females. Amblyopia was predominant among anisometropic patients (75%) with maximum of refractive error difference between 2.00 D to 4.00 D. Amongst them, maximum amblyopes were having hypermetropia with astigmatism (37.50%). In the strabismic type, esotropia was more common. Patients showing more than 2 Snellen's line improvements after patching for 2 hrs. were 77.27% and for 6 hrs. were 22.72%. After part-time patching, maximum improvement in BCVA (best corrected visual acuity) was seen in anisometropes (P<0.0001) followed by strabismic (P=0.025) and least with mixed (P=0.026) amblyopes. CONCLUSION Amblyopia is treatable if detected earlier. Lack of community or preschool vision screening was the main cause for late pickup of amblyopic children for timely management and hence significant visual impairment associated with the condition.
Effect of Age on Response to Amblyopia Treatment in Children
Archives of Ophthalmology, 2011
Objective-To determine whether age at initiation of amblyopia treatment influences the response among children 3 to <13 years of age with unilateral amblyopia 20/40 to 20/400. Methods-A meta-analysis of individual subject data from 4 recently completed randomized amblyopia treatment trials was performed to evaluate the relationship between age and improvement in logMAR amblyopic eye visual acuity. Analyses were adjusted for baseline amblyopic eye visual acuity, spherical equivalent refractive error in the amblyopic eye, type of amblyopia, prior amblyopia treatment, study treatment, and protocol. Age was categorized (3 to <5 years, 5 to <7 years, and 7 to <13 years) because there was a non-linear relationship between age and improvement in amblyopic eye acuity.