A randomized trial to evaluate 2 hours of daily patching for strabismic and anisometropic amblyopia in children (original) (raw)
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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.
A Randomized Trial of Increasing Patching for Amblyopia
Ophthalmology, 2013
Objective-After treatment with refractive correction and patching, some patients have residual amblyopia resulting from strabismus or anisometropia. We conducted a clinical trial to evaluate the effectiveness of increasing prescribed daily patching from 2 to 6 hours in children with stable residual amblyopia. Design-Prospective, randomized, multicenter clinical trial. Participants-A total of 169 children aged 3 to <8 years (mean, 5.9 years) with stable residual amblyopia (20/32-20/160) after 2 hours of daily patching for at least 12 weeks. Intervention-Random assignment to continue 2 hours of daily patching or increase patching time to an average of 6 hours/day. Main Outcome Measures-Best-corrected visual acuity (VA) in the amblyopic eye after 10 weeks. Results-Baseline VA was 0.44 logarithm of the minimum angle of resolution (logMAR) (20/50 −2). Ten weeks after randomization, amblyopic eye VA had improved an average of 1.2 lines in the 6-hour group and 0.5 line in the 2-hour group (difference in mean VA adjusted for acuity at randomization = 0.6 line; 95% confidence interval, 0.3-1.0; P = 0.002). Improvement of 2 or more lines occurred in 40% of participants patched for 6 hours versus 18% of those who continued to patch for 2 hours (P = 0.003).
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.
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.
Objectively monitored patching regimens for treatment of amblyopia: randomised trial
BMJ, 2007
Objectives To compare visual outcome in response to two prescribed rates of occlusion (six hours a day and 12 hours a day). Design Unmasked randomised trial. Setting Research clinics in two London hospitals. Participants 97 children with a confirmed diagnosis of amblyopia associated with strabismus, anisometropia, or both. Interventions: 18 week period of wearing glasses (refractive adaptation) followed by occlusion prescribed ("patching") for six or 12 hours a day. Main outcome measures Visual acuity measured by logMAR letter recognition; objectively monitored rate of occlusion (hours a day). Results The mean age of children at study entry was 5.6 (SD 1.5) years. Ninety were eligible for occlusion but 10 dropped out in this phase, leaving 80 children who were randomised to a prescribed dose rate of six (n=40) or 12 (n=40) hours a day. The mean change in visual acuity of the amblyopic eye was not significantly different (P=0.64) between the two groups (0.26 (95% confidence interval 0.21 to 0.31) log units in six hour group; 0.24 (0.19 to 0.29) log units in 12 hour group). The mean dose rates (hours a day) actually received, however, were also not significantly different (4.2 (3.7 to 4.7) in six hour group v 6.2 (5.1 to 7.3) in 12 hour group; P=0.06). The visual outcome was similar for those children who received three to six hours a day or more than six to 12 hours a day, but significantly better than that in children who received less than three hours a day. Children aged under 4 required significantly less occlusion than older children. Visual outcome was not influenced by type of amblyopia. Conclusions Substantial (six hours a day) and maximal (12 hours a day) prescribed occlusion results in similar visual outcome. On average, the occlusion dose received in the maximal group was only 50% more than in the substantial group and in both groups was much less than that prescribed. Younger children required the least occlusion. Trials registration Clinical Trials NCT00274664.
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.
Objective: To evaluate the effectiveness of treatment of amblyopia in children aged 7 to 17 years. Methods: At 49 clinical sites, 507 patients with ambly-opic eye visual acuity ranging from 20/40 to 20/400 were provided with optimal optical correction and then ran-domized 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 (2 lines) by 24 weeks were considered responders. Results: In the 7-to 12-year-olds (n = 404), 53% of the treatment group were responders compared with 25% of the optical correction group (P.001). In the 13-to 17-year-olds (n=103), the responder rates were 25% and 23%, respectively, overall (adjusted P=.22) but 47% and 20%, respectively, among patients not previously treated with patching and/or atropine for amblyopia (adjusted P=.03). Most patients, including responders, were left with a residual visual acuity deficit. Conclusions: Amblyopia improves with optical correction alone in about one fourth of patients aged 7 to 17 years, although most patients who are initially treated with optical correction alone will require additional treatment for amblyopia. For patients aged 7 to 12 years, prescribing 2 to 6 hours per day of patching with near visual activities and atropine can improve visual acuity even if the amblyopia has been previously treated. For patients 13 to 17 years, prescribing patching 2 to 6 hours per day with near visual activities may improve visual acu-ity when amblyopia has not been previously treated but appears to be of little benefit if amblyopia was previously treated with patching. We do not yet know whether visual acuity improvement will be sustained once treatment is discontinued; therefore, conclusions regarding the long-term benefit of treatment and the development of treatment recommendations for amblyopia in children 7 years and older await the results of a follow-up study we are conducting on the patients who responded to treatment.