Digital therapeutic improves visual acuity and encourages high adherence in amblyopic children in open-label pilot study.

BACKGROUND: The effectiveness of amblyopia therapy can be limited by poor adherence. Dichoptic therapies are a new approach, but recent trials have demonstrated difficulty maintaining high adherence over extended periods of at-home treatment. We evaluated the efficacy and adherence of Luminopia One-a dichoptic treatment that applies therapeutic modifications to streaming content chosen by the patient. METHODS: This single-arm, multicenter prospective pilot study enrolled children aged 4-12 with anisometropic, strabismic, or mixed amblyopia at 10 pediatric ophthalmic and optometric practices across the United States. The therapeutic was prescribed for 1 hour/day, 6 days/week for 12 weeks of at-home use. The primary endpoint was best-corrected visual acuity (BCVA) at the 12-week follow-up visit. RESULTS: In total, 90 participants (mean age, 6.7 ± 2.0 years) were enrolled, and 73/90 participants (81%) had prior treatment beyond refractive correction. For those who completed the 12-week visit, mean amblyopic eye BCVA improved from 0.50 logMAR to 0.35 logMAR (1.5 logMAR lines; 95% CI, 1.2-1.8 lines; P < 0.0001). Mean stereoacuity improved by 0.28 log arcsec (95% CI, 0.14-0.42 log arcsec; P < 0.0001). Median adherence was 86% (interquartile range, 70%-97%). CONCLUSIONS: In our study cohort, adherence over the 12-week study period was high, and participants demonstrated clinically and statistically significant improvements in visual acuity and stereoacuity.

The role of the random dot Stereo Butterfly test as an adjunct test for the detection of constant strabismus in vision screening.

BACKGROUND: A goal of vision screening is the detection of amblyopia risk factors, including strabismus. The random dot Stereo Butterfly test requires no instruction, has a simple pass/fail response with no monocular clues, and is easily administered. The purpose of this study was to determine whether this test could be used as a cost-effective and reliable component of preschool vision screening. METHODS: The Stereo Butterfly was presented to children with no previous history of ocular problems or treatment. The test was presented with the use of polarized glasses at a 16-inch testing distance. A "pass" was recorded if the patient reported seeing a butterfly; a "refer" was denoted otherwise. Vision and motility measurements were recorded, and the patient underwent a complete eye examination with cycloplegic refraction. RESULTS: A total of 281 children 3 to 6 years of age were tested: 221 children passed the test. Of those who passed, 7 (3.2%) had intermittent strabismus, 1 had a small-angle constant strabismus, 60 failed screening for constant strabismus (of whom 24 [40%] had constant strabismus), and 6 were false-negative results. The sensitivity of the Stereo Butterfly for detecting constant strabismus was 96%; the specificity, 86%. CONCLUSIONS: The Stereo Butterfly test may be a valuable adjunctive tool in vision screening programs for the detection of manifest strabismus because it is easy to administer and effectively detects constant strabismus. It has a high specificity for detection of constant strabismus but, if used alone, the low positive predictive value would allow for many false-positive results.