A randomized trial of levodopa as treatment for residual amblyopia in older children.
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ABSTRACT:
SUBMITTER: Pediatric Eye Disease Investigator Group
PROVIDER: S-EPMC4414716 | biostudies-literature | 2015 May
REPOSITORIES: biostudies-literature
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A randomized trial of levodopa as treatment for residual amblyopia in older children.
Repka Michael X MX Kraker Raymond T RT Dean Trevano W TW Beck Roy W RW Siatkowski R Michael RM Holmes Jonathan M JM Beauchamp Cynthia L CL Golden Richard P RP Miller Aaron M AM Verderber Lisa C LC Wallace David K DK
Ophthalmology 20150209 5
<h4>Objective</h4>To assess the efficacy and short-term safety of levodopa as adjunctive treatment to patching for amblyopia.<h4>Design</h4>Randomized, placebo-controlled trial.<h4>Participants</h4>One hundred thirty-nine children 7 to 12 years of age with residual amblyopia resulting from strabismus, anisometropia, or both combined (visual acuity [VA], 20/50-20/400) after patching.<h4>Methods</h4>Sixteen weeks of oral levodopa or placebo administered 3 times daily while patching the fellow eye ...[more]
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Project description:Importance:Fellow 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. Objectives:To 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 Participants:This 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. Interventions:Binocular game and patching as amblyopia treatments. Main Outcomes and Measures:The 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. Results:Among 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 Relevance:A 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 Registration:clinicaltrials.gov Identifier: NCT02365090.
| S-EPMC6054712 | 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
Project description:PURPOSE:To compare visual acuity (VA) improvement in children aged 7 to 12 years with amblyopia treated with a binocular iPad game plus continued spectacle correction vs. continued spectacle correction alone. DESIGN:Multicenter randomized clinical trial. PARTICIPANTS:One hundred thirty-eight participants aged 7 to 12 years with amblyopia (33-72 letters, i.e., approximately 20/200 to 20/40) resulting from strabismus, anisometropia, or both. Participants were required to have at least 16 weeks of optical treatment in spectacles if needed or demonstrate no improvement in amblyopic-eye visual acuity (VA) for at least 8 weeks prior to enrollment. METHODS:Eligible participants (mean age 9.6 years, mean baseline VA of 59.6 letters, history of prior amblyopia treatment other than spectacles in 96%) were randomly assigned to treatment for 8 weeks with the dichoptic binocular Dig Rush iPad game (prescribed for 1 hour per day 5 days per week) plus spectacle wear if needed (n = 69) or continued spectacle correction alone if needed (n = 69). MAIN OUTCOME MEASURES:Change in amblyopic-eye VA from baseline to 4 weeks, assessed by a masked examiner. RESULTS:At 4 weeks, mean amblyopic-eye VA letter score improved from baseline by 1.3 (2-sided 95% confidence interval [CI]: 0.1-2.6; 0.026 logMAR) with binocular treatment and by 1.7 (2-sided 95% CI: 0.4-3.0; 0.034 logMAR) with continued spectacle correction alone. After adjusment for baseline VA, the letter score difference between groups (binocular minus control) was -0.3 (95% CI: -2.2 to 1.5, P = 0.71, difference of -0.006 logMAR). No difference in letter scores was observed between groups when the analysis was repeated after 8 weeks of treatment (adjusted mean: -0.1, 98.3% CI: -2.4 to 2.1). For the binocular group, adherence data from the iPad indicated that slightly more than half of the participants (58% and 56%) completed >75% of prescribed treatment by the 4- and 8-week visits, respectively. CONCLUSIONS:In children aged 7 to 12 years who have received previous treatment for amblyopia other than spectacles, there was no benefit to VA or stereoacuity from 4 or 8 weeks of treatment with the dichoptic binocular Dig Rush iPad game.
| S-EPMC6402824 | biostudies-literature
Project description:To compare weekend atropine sulfate use augmented by a plano lens for the sound eye with weekend atropine use alone for moderate amblyopia in children aged 3 years to younger than 7 years.In a multicenter clinical trial, 180 children with moderate amblyopia (visual acuities of 20/40-20/100) were randomized to weekend atropine use augmented by a plano lens or weekend atropine use alone.Masked assessment of amblyopic eye visual acuity using the Amblyopia Treatment Study HOTV testing protocol at 18 weeks.At 18 weeks, amblyopic eye improvement averaged 2.8 lines in the group that received atropine plus a plano lens and 2.4 lines in the group that received atropine alone (mean difference between groups adjusted for baseline acuity, 0.3 line; 95% confidence interval, -0.2 to 0.8 line). Amblyopic eye visual acuity was 20/25 or better in 24 patients (29%) in the group that received atropine only and 35 patients (40%) in the group that received atropine plus a plano lens (P = .03). More patients in the group that received atropine plus a plano lens had reduced sound eye visual acuity at 18 weeks; however, there were no cases of persistent reverse amblyopia.As an initial treatment for moderate amblyopia, the augmentation of weekend atropine use with a plano lens does not substantially improve amblyopic eye visual acuity when compared with weekend atropine use alone. Application to Clinical Practice Treatment of children with unilateral amblyopia. Trial Registration clinicaltrials.org Identifier: NCT00315302.
| S-EPMC2713107 | biostudies-literature
Project description:BackgroundMost clinical trials of contrast-rebalanced binocular amblyopia treatment used a contrast increment protocol of 10% daily with successful play. Paired with a definition of success requiring only 15-30 min/day of gameplay, this increment protocol could allow children to reach 100% fellow eye contrast in 3-9 hours; however, this may not provide adequate therapeutic time with reduced fellow eye contrast. The purpose of this study was to compare the original protocol against three alternative contrast increment protocols designed to increase the number of treatment hours.MethodsIn this prospective study, 63 amblyopic children (4-10 years; amblyopic eye visual acuity, 20/40-125) were randomly assigned one of four daily contrast increment protocols for 4 weeks, all starting with 20% fellow eye contrast: 10%, 5%, 0%, or 10% for first 4 weeks then reset to 20% and repeat 10% increment for the final 4 weeks. Children played contrast-rebalanced games for 1 hour/day, 5 days/week. Best-corrected visual acuity, stereoacuity, and suppression were assessed at baseline and every 2 weeks until the 8-week outcome visit.ResultsAt baseline, mean amblyopic eye best-corrected visual acuity was 0.47 ± 0.14 logMAR (20/60), improving overall 0.14 ± 0.08 logMAR (1.4 lines; P < 0.0001) at 8 weeks. All four protocols resulted in similar improvement in visual acuity (0.13-0.16 logMAR; all Ps < 0.0002). Stereoacuity and suppression also improved (all Ps < 0.05).ConclusionsNone of the new protocols resulted in less improvement than the original 10% contrast increment protocol. Contrast-rebalanced binocular games yielded significant improvements in visual acuity, stereoacuity, and suppression with or without daily contrast increments.
| S-EPMC8328197 | biostudies-literature
Project description:BackgroundBinocular neural architecture may be preserved in children with deprivation amblyopia due to unilateral cataract. The purpose of this study was to investigate whether a contrast-rebalanced binocular treatment, recently used with success to treat the interocular suppression and amblyopia in strabismic and anisometropic children, can contribute to rehabilitation of visual acuity in children with deprivation amblyopia secondary to monocular cataract.MethodsIn a pilot randomized trial, 15 children (4-13 years of age) were enrolled and randomized to continue with their current treatment only (n = 7) or to continue with their current treatment and add contrast-rebalanced binocular iPad game play 5 hours/week for 4 weeks (n = 8). The primary outcome was change in visual acuity at 4 weeks.ResultsAlthough 10 of 15 participants were patching, there was little change in visual acuity during the 3 months prior to enrollment. At the 4-week primary outcome visit, the mean improvement in visual acuity for the binocular game group was significantly greater than that for the current-treatment group (0.08 ± 0.10 logMAR vs -0.03 ± 0.05 logMAR [t10.2 = 2.53, P = 0.03]). None of the children who had dense congenital cataract achieved improved visual acuity with binocular treatment.ConclusionsIn this study cohort, visual acuity improved over 8 weeks in children with unilateral deprivation amblyopia who played a binocular contrast-rebalanced binocular iPad game.
| S-EPMC8005476 | biostudies-literature
Project description:Purpose:To 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™. Methods:In 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. Results:BCVA 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). Conclusions:I-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:Recent experimental evidence supports a role for binocular visual experience in the treatment of amblyopia. The purpose of this study was to determine whether repeated binocular visual experience with dichoptic iPad games could effectively treat amblyopia in preschool children.A total of 50 consecutive amblyopic preschool children 3-6.9 years of age were assigned to play sham iPad games (first 5 children) or binocular iPad games (n = 45) for at least 4 hours per week for 4 weeks. Thirty (67%) children in the binocular iPad group and 4 (80%) in the sham iPad group were also treated with patching at a different time of day. Visual acuity and stereoacuity were assessed at baseline, at 4 weeks, and at 3 months after the cessation of game play.The sham iPad group had no significant improvement in visual acuity (t4 = 0.34, P = 0.75). In the binocular iPad group, mean visual acuity (plus or minus standard error) improved from 0.43 ± 0.03 at baseline to 0.34 ± 0.03 logMAR at 4 weeks (n = 45; paired t44 = 4.93; P < 0.0001). Stereoacuity did not significantly improve (t44 = 1.35, P = 0.18). Children who played the binocular iPad games for ?8 hours (?50% compliance) had significantly more visual acuity improvement than children who played 0-4 hours (t43 = 4.21, P = 0.0001).Repeated binocular experience, provided by dichoptic iPad game play, was more effective than sham iPad game play as a treatment for amblyopia in preschool children.
| S-EPMC4346708 | 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: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