Real-world effectiveness of a binocular, dual-mechanism therapy in severe amblyopia: analysis from the PUPiL Registry.

Effect of vision therapy on children and adults with amblyopia who showed plateaued improvement after occlusion therapy.

PURPOSE To evaluate long‑term visual acuity (VA) trends following a structured vision therapy protocol in patients with amblyopia who had plateaued after conventional occlusion therapy. METHODS This prospective cohort study included 157 patients diagnosed with amblyopia who showed no further VA improvement over at least three consecutive assessments during standard patching. All participants received individualized vision therapy comprising monocular and binocular exercises, fusion training, fixation stabilization, and perceptual tasks, combined with limited daily occlusion (1-3 hours). Therapy was delivered over 15 weekly in‑clinic sessions, followed by a structured home program. Visual acuity was monitored every 6 months over a 48‑month follow‑up period. RESULTS A total of 177 amblyopic eyes from 157 patients (mean age 15.56 ± 10.6 years) were analyzed. Mean VA improved from 0.50 ± 0.23 at baseline to 0.70 ± 0.28 at 48 months (p < .001); 48.6% of eyes achieved a final VA of ≥0.8 decimal. Significant VA gains were observed across all age groups, with mean improvements of 0.24, 0.21, and 0.16 in decimal VA for ages ≤ 8 years, 8-18 years, and >18 years, respectively. The proportion of patients gaining ≥ 2 lines of VA was highest in the ≤8 years (62.5%) and 8-18 years (62.5%) groups, compared with 35.4% in those > 18 years. Isoametropic amblyopia showed the highest rate of ≥2‑line improvement (65.0%), followed by strabismic (63.6%) and anisometropic (44.2%) types. No statistically significant difference in visual outcomes was observed between the two protocols (Haidinger's brushes/flashing vs. adding perceptual learning; p = .385). CONCLUSION Vision therapy can produce clinically meaningful and durable visual improvements in amblyopic patients who no longer respond to occlusion alone. The present study also supports extending amblyopia treatment into adolescence and adulthood, while emphasizing the need for tailored approaches based on the etiology of amblyopia and age.

Effectiveness of Active Vision Therapy in Children with Bilateral Refractive Amblyopia

Administering vision therapy in conjunction with patching significantly improved VA, stereo acuity, and accommodation facility in bilateral refractive amblyopia compared to patching alone.

Use of Dichoptic Therapy for Deprivation Amblyopia: A Single Institution Study.

PURPOSE To report the treatment of deprivation amblyopia with Luminopia (Luminopia, Inc), a digital therapeutic device using dichoptic viewing that received U.S. Food and Drug Administration approval for the treatment of anisometropic amblyopia in children 4 to 12 years of age. METHODS Twenty-two pediatric patients prescribed the Luminopia device for deprivation amblyopia following childhood cataract or glaucoma surgery or congenital corneal opacity with at least 3 months of follow-up were identified. Best corrected visual acuity (BCVA) was compared to pretreatment at each follow-up visit. Total prescribed hours, usage, adherence, and completion of supplemental amblyopia treatment were analyzed. RESULTS Fifty-five percent of patients were boys, and the average age was 6.45 ± 3.0 years (mild to moderate amblyopia: 7.0 ± 3.1 years; severe amblyopia: 6.0 ± 3.0 years). At the 3-month follow-up visit, in the mild to moderate amblyopia cohort, 5 of the 8 patients (62.5%) showed at least one line of improvement in their BCVA in the amblyopic eye. One patient (12.5%) had the same BCVA, and 2 (25%) had decreased BCVA. In contrast, in the severe amblyopic cohort, 6 patients (50%) had improved, 5 (42%) had stable BCVA, and 1 (8%) had decreased BCVA. CONCLUSIONS Use of a dichoptic digital therapeutic device in the treatment and management of amblyopia holds exciting potential in deprivation amblyopia. Those with mild to moderate amblyopia appear to achieve greater visual acuity improvement compared to those with severe amblyopia, although a percentage of patients with severe amblyopia did show modest improvement.

A multinational randomized clinical trial of an eye-tracking-based binocular amblyopia treatment in children aged 4-9 years.

This randomized controlled study compared efficacy and safety of a novel binocular, eye-tracking-based home amblyopia treatment (CureSight) to patching. Three cohorts (China, Israel, U.S.) enrolled 197 children aged 4 to < 9 years with anisometropic, small-angle strabismic, or mixed-mechanism amblyopia at 15 academic/community sites (modified intent-to-treat); 156 completed ≥ 60% of prescribed dosage (per-protocol). CureSight: 90 min/day, 5 days/week for 16 weeks (120 h); patching: 2 h/day, 7 days/week (224 h). In the modified intent-to-treat dataset, visual acuity improvement from baseline to week 16 in the binocular group was noninferior to the patching group (0.028 logMAR; 95% CI - 0.007 to 0.063). In the per-protocol dataset, binocular treatment was superior to patching (0.04 logMAR; 95% CI 0.004 to 0.076). Improvement was significantly affected by baseline covariates of age, baseline vision levels, and previous amblyopia treatment. There was no significant between-group difference in the magnitude of improvement in stereoacuity in either dataset. Overall, CureSight was noninferior to patching in these amblyopia types and yielded better visual outcomes in children completing ≥ 60% dosage, supporting binocular therapy as an additional first-line option.

Effect of active vision therapy on contrast sensitivity in bilateral amblyopia.

AIM To evaluate the effectiveness of combining patching with active vision therapy, compared to patching with placebo training on contrast sensitivity (CS) in pediatric participants with bilateral refractive amblyopia. METHODS In this double-blind, clinical trial, 43 participants aged 5-8 with bilateral refractive amblyopia, unresponsive to spectacles, were randomly assigned to either the experimental group (active vision therapy plus patching) or the control group (placebo treatment with patching) for four months. Active therapy included anti-suppression, accommodative, vergence, and visual memory exercises. CS was measured at baseline and after four months, serving as key outcome measures. RESULTS Forty participants (20 in each group) completed the study. The mean age for the experimental group (5 males) was 6.10±0.84y, and 6.50±1.15y for the control group (11 males). CS in the experimental group improved by 0.10 log (right eye), 0.14 log (left eye), and 0.07 log binocularly (P≤0.03). The control group showed no statistically significant enhancements in monocular or binocular CS (P≥0.07). Compared to the control group, the experimental group demonstrated a rate of change in monocular CS of 0.05 during follow-up time. CONCLUSION Active vision therapy leads to significant and accelerates improvements in CS among children with bilateral refractive amblyopia.

Treatment of Ametropic Amblyopia and the Significance of Cycloplegia in Childhood.