Moderate Amblyopia In Children Research Articles

Intense versus standard regimens of intermittent occlusion therapy for unilateral moderate amblyopia in children: study protocol for a randomized controlled trial

BackgroundWe reported that in our previous study that wearing intermittent occlusion therapy glasses (IO-therapy) for 4 hours (h) was non-inferior to patching for 2 h in 3 to 8-year-old children with amblyopia. We hypothesize that an intense regimen of 12-h IO-therapy per day for 4 weeks could be as effective as the standard regimen of 4-h IO-therapy per day for 12 weeks in treating moderate amblyopia in 3 to 8-year-old children.Methods/DesignA total of 56 children between 3 and 8 years of age with amblyopia in association with anisometropia and/or strabismus will be enrolled. All participants will be prescribed IO-therapy glasses (Amblyz™), set at 30-s opaque/transparent intervals (i.e., occluded 50% of wear time). They will be randomized to receive the standard regimen for 12 weeks or the intense regimen for 4 weeks. Adherence to using the IO-therapy glasses will be objectively monitored in each participant by means of a microsensor dose monitor. The primary study objective is to compare the effectiveness of an intense regimen to a standard regimen of IO-therapy in 3 to 8-year-old children with moderate amblyopia. The secondary study objectives are to determine whether adherence differs between an intense regimen and a standard regimen of IO-therapy, and to determine the dose-response relationship of IO-therapy.DiscussionIn addition to testing the effectiveness, this study will test for the first time the association between treatment adherence and the visual outcome of IO-therapy, which will enhance our understanding of the dose-response relationship of IO-therapy. If an intense regimen is shown to be effective, it would alter amblyopia treatment strategies and improve visual outcomes.Trial registrationClinicalTrials.gov: NCT02767856. Registered on 10 May 2016.

A Randomized Trial Comparing Bangerter Filters and Patching for the Treatment of Moderate Amblyopia in Children

To determine whether visual acuity improvement with Bangerter filters is similar to improvement with patching as initial therapy for children with moderate amblyopia. Randomized, clinical trial. We enrolled 186 children, 3 to <10 years old, with moderate amblyopia (20/40-20/80). Children were randomly assigned to receive either daily patching or to use a Bangerter filter on the spectacle lens in front of the fellow eye. Study visits were scheduled at 6, 12, 18, and 24 weeks. Visual acuity in amblyopic eyes at 24 weeks. At 24 weeks, amblyopic eye improvement averaged 1.9 lines in the Bangerter group and 2.3 lines in the patching group (difference in mean visual acuities between groups adjusted for baseline acuity = 0.38 line). The upper limit of a 1-sided 95% confidence interval was 0.76 line, which slightly exceeded a prespecified noninferiority limit of <0.75 line. Similar percentages of subjects in each group improved > or =3 lines (Bangerter group 38% vs patching group 35%; P = 0.61) or had > or =20/25 amblyopic eye acuity (36% vs 31%, respectively; P = 0.86). There was a lower treatment burden in the Bangerter group as measured with the Amblyopia Treatment Index. With Bangerter filters, neither a fixation switch to the amblyopic eye nor induced blurring in the fellow eye to worse than that of the amblyopic eye was required for visual acuity improvement. Because the average difference in visual acuity improvement between Bangerter filters and patching was less than half a line, and there was lower burden of treatment on the child and family, Bangerter filter treatment is a reasonable option to consider for initial treatment of moderate amblyopia.

Part-time occlusion therapy for amblyopia in older children

To compare the efficacy of part-time versus full-time occlusion for treatment of amblyopia in children aged 7-12 years. Prospective interventional case series. One hundred children between 7-12 years of age with anisometropic (57), strabismic (25) and mixed (18) unilateral amblyopia were randomized (simple randomization) into four groups (25 each) to receive two hours, four hours, six hours or full-time occlusion therapy. Children were regularly followed up at six-weekly intervals for a minimum of three visits. Intragroup visual improvement was analyzed using paired t-test while intergroup comparisons were done using ANOVA and unpaired t-test. All four groups showed significant visual improvement after 18 weeks of occlusion therapy ( P < 0.001). Seventy-three (73%) of the total 100 eyes responded to amblyopia therapy with 11 eyes (44%), 17 eyes (68%), 22 eyes (88%) and 23 eyes (92%) being amblyopia responders in the four groups respectively, with the least number of responders in the two hours group. In mild to moderate amblyopia (vision 20/30 to 20/80), there was no significant difference in visual outcome among the four groups ( P =0.083). However, in severe amblyopia (vision 20/100 or worse), six hours ( P =0.048) and full-time occlusion ( P =0.027) treatment were significantly more effective than two hours occlusion. All grades of part-time occlusion are comparable to full-time occlusion in effectiveness of treatment for mild to moderate amblyopia in children between 7-12 years of age unlike in severe amblyopia, where six hours and full-time occlusion were more effective than two hours occlusion therapy.

The effect of the randomized trial of patching regimens for treatment of moderate amblyopia on pediatric ophthalmologists: 3-year outcome

To investigate whether the recommendations of the randomized trial of patching regimens for treatment of moderate amblyopia in children have been adopted by pediatric ophthalmologists 3 years after publication. An identical questionnaire to that emailed 3 years ago (6 months after publication of the randomized trial) was emailed to 560 members of the American Association for Pediatric Ophthalmology and Strabismus. One hundred seven (20%) responses were received. Fifty-five percent of respondents had decreased their prescribed patching regimens at least sometimes as compared with 28% (p = 0.0005) in 2003. There was no significant increase in the prescription of near visual tasks or only 2 hour patching regimens. Our study suggests that pediatric ophthalmologists may be prescribing fewer patching hours in 2006 in comparison to 2003. However, the majority of ophthalmologists are still reluctant to patch for only 2 hours, and there has not been a significant increase in prescribing near visual tasks during patching.

Two-Year Follow-up of a 6-Month Randomized Trial of Atropine Vs Patching for Treatment of Moderate Amblyopia in Children

Two-Year Follow-up of a 6-Month Randomized Trial of Atropine Vs Patching for Treatment of Moderate Amblyopia in Children

Two-Year Follow-up of a 6-Month Randomized Trial of Atropine vs Patching for Treatment of Moderate Amblyopia in Children

To compare patching and atropine sulfate as treatments for moderate amblyopia in children 18 months after completion of a 6-month randomized trial. In a randomized, multicenter (47 sites) clinical trial, 419 children younger than 7 years with amblyopia (20/40 to 20/100 in the affected eye) were assigned to receive either patching or atropine eye drops for 6 months. Between 6 months and 2 years, treatment was at the discretion of the investigator. Main Outcome Measure Visual acuity in the amblyopic eye and sound eye after 2 years. At 2 years, visual acuity in the amblyopic eye improved from baseline a mean of 3.7 lines in the patching group and 3.6 lines in the atropine group. The difference in visual acuity between treatment groups was small: 0.01 logMAR (95% confidence interval, -0.02 to 0.04). In both treatment groups, the mean amblyopic eye acuity was approximately 20/32, 1.8 lines worse than the mean sound eye acuity, which was approximately 20/20. Atropine or patching for 6 months followed by best clinical care until 2 years produced similar improvement of moderate amblyopia in children between 3 and 7 years of age at enrollment. However, on average the amblyopic eye acuity was still approximately 2 lines worse than the sound eye.

A randomized trial of atropine regimens for treatment of moderate amblyopia in children

To compare daily atropine to weekend atropine as prescribed treatments for moderate amblyopia in children younger than 7 years. Prospective, randomized multicenter clinical trial (30 sites). One hundred sixty-eight children younger than 7 years with amblyopia in the range of 20/40 to 20/80 associated with strabismus, anisometropia, or both. Randomization either to daily atropine or to weekend atropine for 4 months. Partial responders were continued on the randomized treatment until no further improvement was noted. Visual acuity (VA) in the amblyopic eye after 4 months. The improvement in VA of the amblyopic eye from baseline to 4 months averaged 2.3 lines in each group. The VA of the amblyopic eye at study completion was either (1) at least 20/25 or (2) better than or equal to that of the sound eye in 39 children (47%) in the daily group and 45 children (53%) in the weekend group. The VA of the sound eye at the end of follow-up was reduced by 2 lines in one patient in each group. Stereoacuity outcomes were similar in the 2 groups. Weekend atropine provides an improvement in VA of a magnitude similar to that of the improvement provided by daily atropine in treating moderate amblyopia in children 3 to 7 years old. This article contains additional online-only material available at http://www.ophsource.com/periodicals/ophtha.

A Randomized Trial of Patching Regimens for Treatment of Moderate Amblyopia in Children

A Randomized Trial of Patching Regimens for Treatment of Moderate Amblyopia in Children

Clinical research in pediatric ophthalmology: the Pediatric Eye Disease Investigator Group.

The Pediatric Eye Disease Investigator Group (PEDIG) is a network of university-based and community-based pediatric eye care practitioners that is conducting multiple clinical research studies. The group has conducted the Congenital Esotropia Observational Study, which assessed the early course of esotropia in infants, and the Amblyopia Treatment Studies, a series of randomized trials, the first of which compared atropine and patching for treatment of moderate amblyopia in children 3 to <7 years old. Herein, the results of these studies are summarized, and the current and future studies of the group are described.

Atropine vs Patching for Treatment of Amblyopia in Children

ObjectiveTo compare patching and atropine as treatments for moderate amblyopia in children younger than 7 years.MethodsIn a randomized clinical trial, 419 children younger than 7 years with amblyopia and visual acuity in the range of 20/40 to 20/100 were assigned to receive either patching or atropine at 47 clinical sites.Main Outcome MeasureVisual acuity in the amblyopic eye and sound eye after 6 months.ResultsVisual acuity in the amblyopic eye improved in both groups (improvement from baseline to 6 months was 3.16 lines in the patching group and 2.84 lines in the atropine group). Improvement was initially faster in thepatching group, but after 6 months, the difference in visual acuity between treatment groups was small and clinically inconsequential (mean difference at 6 months, 0.034 logMAR units; 95% confidence interval, 0.005-0.064 logMAR units). The 6-month acuity was 20/30 or better in the amblyopic eye and/or improved from baseline by 3 or more lines in 79% of the patching group and 74% of the atropine group. Both treatments were well tolerated, although atropine had a slightly higher degree of acceptability on a parental questionnaire. More patients in the atropine group than in the patching group had reduced acuity in the sound eye at 6 months, but this did not persist with further follow-up.ConclusionAtropine and patching produce improvement of similar magnitude, and both are appropriate modalities for the initial treatment of moderate amblyopia in children aged 3 to less than 7 years.