Randomized trial to evaluate combined patching and atropine for residual amblyopia.
Ontology highlight
ABSTRACT:
SUBMITTER: Pediatric Eye Disease Investigator Group (PEDIG) Writing Committee
PROVIDER: S-EPMC3156057 | biostudies-literature | 2011 Jul
REPOSITORIES: biostudies-literature
Publications
Randomized trial to evaluate combined patching and atropine for residual amblyopia.
Wallace David K DK Kraker Raymond T RT Beck Roy W RW Cotter Susan A SA Davis Patricia L PL Holmes Jonathan M JM Repka Michael X MX Suh Donny W DW
Archives of ophthalmology (Chicago, Ill. : 1960) 20110701 7
Similar Datasets
Project description:ImportancePatching is often less effective for severe amblyopia because of poor adherence. For the treatment of severe amblyopia, although combined atropine and patching therapy (CAPT) has been found to be efficacious, it is currently unknown whether CAPT is more efficacious than patching alone.ObjectiveTo compare the efficacy of CAPT vs patching alone in children aged 3 to 12 years with severe amblyopia.Design, setting, and participantsThis single-center randomized clinical trial was conducted from November 2018 to May 2020. The visual acuity (VA) examiner was masked to the treatment groups. The follow-up visits were at 3 months and 6 months. Participants aged 3 to 12 years with severe amblyopia (20/100 to 20/500) resulting from strabismus, anisometropia, or both were randomly assigned to CAPT or patching therapy.InterventionsCAPT or patching alone for 6 months.Main outcomes and measuresChange of the amblyopic eye VA from baseline to 6 months.ResultsAmong 108 participants, the mean (SD) age was 5.2 (1.8) years, and 54 (50%) were female. Overall, 53 participants (49%) were randomized to CAPT and 55 (51%) were randomized to patching therapy. At baseline, the mean (SD) amblyopic eye VA was 0.95 (0.22) logMAR (approximately 20/200 [2.2 lines]). At 6 months, the CAPT group's mean improvement in amblyopic eye VA was 0.72 logMAR (7.2 lines) compared with 0.58 logMAR (5.8 lines) in the patching alone group (difference, 0.14 logMAR [1.4 lines] greater in the CAPT group; 95% CI, 0.05-0.22 logMAR [0.5-2.2 lines]; P = .002). The amblyopic eye VA improvement in the CAPT group also was greater than that in the patching alone group at 3 months (difference in the means, 0.13 logMAR [1.3 lines]; 95% CI, 0.04-0.22 logMAR [0.4-2.2 lines]; P = .004). No participants were withdrawn because of adverse effects.Conclusions and relevanceCAPT resulted in more mean improvement of amblyopic eye VA than patching alone among participants enrolled in this trial, although the clinical relevance of this relatively small VA difference cannot be determined from this trial.Trial registrationChinese Clinical Trial Registry Identifier: ChiCTR1800018663.
| S-EPMC8283662 | biostudies-literature
Project description:ObjectiveTo compare patching with atropine eyedrops in the treatment of moderate amblyopia (visual acuity, 20/40-20/100) in children aged 7 to 12 years.MethodsIn a randomized, multicenter clinical trial, 193 children with amblyopia were assigned to receive weekend atropine or patching of the sound eye 2 hours per day. Main Outcome Measure Masked assessment of visual acuity in the amblyopic eye using the electronic Early Treatment Diabetic Retinopathy Study testing protocol at 17 weeks.ResultsAt 17 weeks, visual acuity had improved from baseline by an average of 7.6 letters in the atropine group and 8.6 letters in the patching group. The mean difference between groups (patching - atropine) adjusted for baseline acuity was 1.2 letters (ends of complementary 1-sided 95% confidence intervals for noninferiority, -0.7, 3.1 letters). This difference met the prespecified definition for equivalence (confidence interval <5 letters). Visual acuity in the amblyopic eye was 20/25 or better in 15 participants in the atropine group (17%) and 20 in the patching group (24%; difference, 7%; 95% confidence interval, -3% to 17%).ConclusionsTreatment with atropine or patching led to similar degrees of improvement among 7- to 12-year-olds with moderate amblyopia. About 1 in 5 achieved visual acuity of 20/25 or better in the amblyopic eye.Clinical relevanceAtropine and patching achieve similar results among older children with unilateral amblyopia.Trial registration(clinicaltrials.gov) Identifier: NCT00315328.
| S-EPMC2846774 | biostudies-literature
Project description:ObjectiveTo determine the visual acuity outcome at age 10 years for children younger than 7 years when enrolled in a treatment trial for moderate amblyopia.MethodsIn a multicenter clinical trial, 419 children with amblyopia (visual acuity, 20/40-20/100) were randomized to patching or atropine eyedrops for 6 months. Two years after enrollment, a subgroup of 188 children entered long-term follow-up. Treatment after 6 months was at the discretion of the investigator; 89% of children were treated.Main outcome measureVisual acuity at age 10 years with the electronic Early Treatment Diabetic Retinopathy Study test.Application to clinical practicePatching and atropine eyedrops produce comparable improvement in visual acuity that is maintained through age 10 years.ResultsThe mean amblyopic eye acuity, measured in 169 patients, at age 10 years was 0.17 logMAR (logarithm of the minimum angle of resolution) (approximately 20/32), and 46% of amblyopic eyes had an acuity of 20/25 or better. Age younger than 5 years at entry into the randomized trial was associated with a better visual acuity outcome (P < .001). Mean amblyopic and sound eye visual acuities at age 10 years were similar in the original treatment groups (P = .56 and P = .80, respectively).ConclusionsAt age 10 years, the improvement of the amblyopic eye is maintained, although residual amblyopia is common after treatment initiated at age 3 years to younger than 7 years. The outcome is similar regardless of initial treatment with atropine or patching.
| S-EPMC2614351 | biostudies-literature
Project description:ObjectiveAfter 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.DesignProspective, randomized, multicenter clinical trial.ParticipantsA 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.InterventionRandom assignment to continue 2 hours of daily patching or increase patching time to an average of 6 hours/day.Main outcome measuresBest-corrected visual acuity (VA) in the amblyopic eye after 10 weeks.ResultsBaseline 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).ConclusionsWhen amblyopic eye VA stops improving with 2 hours of daily patching, increasing the daily patching dosage to 6 hours results in more improvement in VA after 10 weeks compared with continuing 2 hours daily.
| S-EPMC3833469 | biostudies-literature
Project description:ImportanceInitial treatment for amblyopia of the fellow eye with patching and atropine sulfate eyedrops improves visual acuity. Long-term data on the durability of treatment benefit are needed.ObjectiveTo report visual acuity at 15 years of age among patients who were younger than 7 years when enrolled in a treatment trial for moderate amblyopia.Design, setting, and participantsIn a multicenter clinical trial, 419 children with amblyopia (visual acuity, 20/40 to 20/100) were randomly assigned to patching (minimum of 6 h/d) or atropine sulfate eyedrops, 1% (1 drop daily), for 6 months. Treatment after 6 months was at the discretion of the investigator. Two years after enrollment, an unselected subgroup of 188 children were enrolled into long-term follow-up.InterventionInitial treatment with patching or atropine with subsequent treatment at investigator discretion.Main outcomes and measuresVisual acuity at 15 years of age with the electronic Early Treatment Diabetic Retinopathy Study test in amblyopic and fellow eyes.ResultsMean visual acuity in the amblyopic eye measured in 147 participants at 15 years of age was 0.14 logMAR (approximately 20/25); 59.9% of amblyopic eyes had visual acuity of 20/25 or better and 33.3%, 20/20 or better. Mean interocular acuity difference (IOD) at 15 years of age was 0.21 logMAR (2.1 lines); 48.3% had an IOD of 2 or more lines and 71.4%, 1 or more lines. Treatment (other than spectacles) was prescribed for 9 participants (6.1%) aged 10 to 15 years. Mean IOD was similar at examinations at 10 and 15 years of age (2.0 and 2.1 logMAR lines, respectively; P = .39). Better visual acuity at the 15-year examination was achieved in those who were younger than 5 years at the time of entry into the randomized clinical trial (mean logMAR, 0.09) compared with those aged 5 to 6 years (mean logMAR, 0.18; P < .001). When we compared subgroups based on original treatment with atropine or patching, no significant differences were observed in visual acuity of amblyopic and fellow eyes at 15 years of age (P = .44 and P = .43, respectively).Conclusions and relevanceAt 15 years of age, most children treated for moderate amblyopia when younger than 7 years have good visual acuity, although mild residual amblyopia is common. The outcome is similar regardless of initial treatment with atropine or patching. The results indicate that improvement occurring with amblyopia treatment is maintained until at least 15 years of age.Trial registrationclinicaltrials.gov Identifier: NCT00000170.
| S-EPMC4206086 | biostudies-literature
Project description:BackgroundSome children have residual amblyopia after treatment with atropine eyedrops for amblyopia due to strabismus and/or anisometropia. We conducted a randomized clinical trial to evaluate the effectiveness of augmenting the effect of atropine by changing the lens over the fellow eye to plano in children with residual amblyopia.MethodsA total of 73 children 3 to <8 years of age (mean, 5.8 years) with stable residual amblyopia (range, 20/32 to 20/160, mean 20/63(+1)) were enrolled after at least 12 weeks of atropine treatment of the fellow eye. Participants were randomly assigned to continuing weekend atropine alone or wearing a plano lens over the fellow eye (while continuing atropine). The primary outcome was assessed at 10 weeks, and participants were followed until improvement ceased.ResultsAt the 10-week primary outcome visit, amblyopic-eye visual acuity had improved an average of 1.1 lines with the plano lens and 0.6 lines with atropine only (difference adjusted for baseline visual acuity = + 0.5 line; 95% CI, -0.1 to +1.2). At the primary outcome or later visit when the best-measured visual acuity was observed, the mean amblyopic-eye improvement from baseline was 1.9 lines with the plano lens and 0.8 lines with atropine only.ConclusionsWhen amblyopic-eye visual acuity stops improving with atropine treatment, there may be a small benefit to augmenting atropine therapy with a plano lens over the fellow eye. However, the effect was not statistically significant, and the large confidence interval raises the possibility of no benefit or a benefit larger than we observed. A larger study would be necessary to get a more precise estimate of the treatment effect.
| S-EPMC4354879 | biostudies-literature
Project description:PurposeTo compare the effect of amblyopia therapy on cases who received interactive binocular treatment (I-BiT™) with those who received standard patching of the dominant eye with placebo I-BiT™.MethodsIn this randomized clinical trial, 38 unilateral amblyopic children (3-10 years old) were studied. All unilateral amblyopic children who had best corrected visual acuity (BCVA) worse than 0.30 logMAR or a difference of two Snellen lines of BCVA between their two eyes were included, and children who did not complete at least 75% of amblyopia treatment were excluded from this study. Eventually, a total of 19 and 21 subjects were included in case and control groups, respectively. Cases played I-BiT™ games, while controls had standard patch therapy and played with placebo I-BiT™ games, both for one month. All subjects were examined at baseline and after one-month therapy.ResultsBCVA improved significantly in both groups after one-month treatment (case: P = 0.003, control: P < 0.001), while in comparison with each other, there was not any difference between them (P = 0.52). Although stereopsis improved in the case (P < 0.001) and control (P < 0.001), there was no significant difference between them pre and post-therapy. Our children played games for about 6 h total during one month in both groups, and their compliance was 87.5% and 76% in cases and controls, respectively. Two children were excluded due to their lower compliance of playing I-BiT™ games (n = 38).ConclusionsI-BiT™ game and patching with placebo game had similar BCVA improvement in amblyopic children after one-month treatment. It is suggested to conduct further randomized clinical trials with a larger sample size and longer duration of study and assessment of its recurrence.
| S-EPMC6896467 | biostudies-literature
Project description:ImportanceFellow eye patching has long been the standard treatment for amblyopia, but it does not always restore 20/20 vision or teach the eyes to work together. Amblyopia can be treated with binocular games that rebalance contrast between the eyes so that a child may overcome suppression. However, it is unclear whether binocular treatment is comparable to patching in treating amblyopia.ObjectivesTo assess the effectiveness of a binocular iPad (Apple Inc) adventure game as amblyopia treatment and compare this binocular treatment with patching, the current standard of care.Design, setting, and participantsThis investigation was a randomized clinical trial with a crossover design at a nonprofit eye research institute. Between February 20, 2015, and January 4, 2016, a total of 28 patients were enrolled in the study, with 14 randomized to binocular game treatment and 14 to patching treatment.InterventionsBinocular game and patching as amblyopia treatments.Main outcomes and measuresThe primary outcome was change in amblyopic eye best-corrected visual acuity (BCVA) at the 2-week visit. Secondary outcomes were change in stereoacuity and suppression at the 2-week visit and change in BCVA at the 4-week visit.ResultsAmong 28 children, the mean (SD) age at baseline was 6.7 (1.4) years (age range, 4.6-9.5 years), and 7 (25%) were female. At baseline, the mean (SD) amblyopic eye BCVA was 0.48 (0.14) logMAR (approximately 20/63; range, 0.3-0.8 logMAR [20/40 to 20/125]), with 14 children randomized to the binocular game and 14 to patching for 2 weeks. At the 2-week visit, improvement in amblyopic eye BCVA was greater with the binocular game compared with patching, with a mean (SD) improvement of 0.15 (0.08) logMAR (mean [SD], 1.5 [0.8] lines) vs 0.07 (0.08) logMAR (mean [SD], 0.7 [0.8] line; P = .02) after 2 weeks of treatment. These improvements from baseline were significant for the binocular game (mean [SD] improvement, 1.5 [0.8] lines; P < .001) and for patching (mean [SD] improvement, 0.7 [0.8] line; P = .006). Depth of suppression improved from baseline at the 2-week visit for the binocular game (mean [SD], 4.82 [2.82] vs 3.24 [2.87]; P = .03) and for patching (mean [SD], 4.77 [3.10] vs 2.57 [1.67]; P = .004). Patching children crossed over to binocular game treatment, and all 28 children played the game for another 2 weeks. At the 4-week visit, no group difference was found in BCVA change, with children who crossed over to the binocular games catching up with children treated with binocular games, for a mean (SD) improvement of 0.17 (0.10) logMAR (mean [SD], 1.7 [1.0] lines) for the binocular game vs a mean (SD) improvement of 0.16 (0.12) logMAR (mean [SD], 1.6 [1.2] lines) for the patching crossover (P = .73).Conclusions and relevanceA binocular iPad game was effective in treating childhood amblyopia and was more efficacious than patching at the 2-week visit. Binocular games that rebalance contrast to overcome suppression are a promising additional option for treating amblyopia.Trial registrationclinicaltrials.gov Identifier: NCT02365090.
| S-EPMC6054712 | biostudies-literature
Project description:ObjectivesTo compare visual outcome in response to two prescribed rates of occlusion (six hours a day and 12 hours a day).DesignUnmasked randomised trial.SettingResearch clinics in two London hospitals.Participants97 children with a confirmed diagnosis of amblyopia associated with strabismus, anisometropia, or both.Interventions18 week period of wearing glasses (refractive adaptation) followed by occlusion prescribed ("patching") for six or 12 hours a day.Main outcome measuresVisual acuity measured by logMAR letter recognition; objectively monitored rate of occlusion (hours a day).ResultsThe 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.ConclusionsSubstantial (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 registrationClinical Trials NCT00274664.
| S-EPMC2001048 | biostudies-literature
Project description:ObjectiveTo determine whether visual acuity improvement with Bangerter filters is similar to improvement with patching as initial therapy for children with moderate amblyopia.DesignRandomized, clinical trial.ParticipantsWe enrolled 186 children, 3 to <10 years old, with moderate amblyopia (20/40-20/80).MethodsChildren 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.Main outcome measuresVisual acuity in amblyopic eyes at 24 weeks.ResultsAt 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.ConclusionsBecause 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.
| S-EPMC2864338 | biostudies-literature