OVP 14-2 Final Version New Newest

Optometry & Visual Performance 155 Volume 14 | Issue 2 | June 2026 Luminopia Luminopia is a prescription digital therapeutic for amblyopia, the first FDA-cleared device of its kind. It received FDA clearance in 2021, with a commercial launch in 2023, and is indicated for children ages 4–12 with amblyopia secondary to anisometropia or mild strabismus (under 5 prism diopters). The core mechanism is dichoptic therapy: presenting different images to the right and left eye simultaneously to reduce the brain’s suppression of the amblyopic eye and to encourage both eyes to work together. What makes Luminopia unique in its delivery is that, rather than games or abstract exercises, children watch their own selected TV shows and movies through a virtual reality headset. The software modifies streaming content in real time, applying a global contrast reduction to the fellow eye so that the brain must rely on the amblyopic eye’s input to perceive the full image. The result is a treatment that feels less like therapy and more like screen time. The standard prescribed dose is one hour per day, six days per week. Parents have access to a monitoring portal that lets them track their child’s daily usage and select content from an approved library, providing families with both oversight and a degree of personalization. Xiao et al.5 conducted the pivotal Phase 3 randomized controlled trial, enrolling 105 children ages 4–7 with unilateral amblyopia from anisometropia, strabismus, or both, with amblyopic eye visual acuity between 20/40 and 20/200. Children were randomized 1:1 to Luminopia plus glasses versus glasses alone for 12 weeks. The Luminopia group improved by 1.8 lines in visual acuity compared to 0.8 lines in the glasses-only group, a statistically significant difference of 1.0 line. Notably, 62% of Luminopia-treated children achieved two or more lines of improvement, compared to 33% in the control group (glasses only), and median adherence reached 88%. These results were compelling enough that the trial was stopped early for success and formed the basis for FDA clearance. CureSight CureSight is a prescription, FDA-cleared, homebased dichoptic treatment for amblyopia that combines real-time eye tracking technology, redblue anaglyph glasses, and streamed video content. It is indicated for children ages 4 to under 9 with anisometropic, small-angle strabismic (up to 5 prism diopters) or mixed-mechanism amblyopia, with amblyopic eye visual acuity between 20/32 and 20/100.6,7 As with Luminopia, children watch their own selected TV shows and movies, but the technology behind CureSight is distinctly different. Rather than applying a global contrast reduction to the fellow eye, CureSight uses a built-in eye tracker on an 11.6-inch computer monitor to continuously track each eye’s gaze in real time. Using this gaze data, the software applies a targeted, dynamic blur specifically around the fovea of the stronger fellow eye—only where that eye is actually looking, moment by moment—while leaving the amblyopic eye’s view completely sharp and unaffected. The blur diameter and intensity are automatically calibrated to each child’s measured visual acuity: the worse the amblyopia, the larger and stronger the blur applied to the fellow eye. The prescribed dose is 90 minutes per day, five days per week for 16 weeks, totaling 120 hours of treatment. The pivotal evidence comes from a prospective, multicenter, randomized, evaluator-masked, controlled noninferiority trial across six sites in Israel that led directly to FDA clearance.8 Children (n=103) were randomized 1:1 to CureSight versus standard patching for 16 weeks. CureSight achieved a mean VA improvement of 2.8 lines, compared with 2.3 lines in the patching group, with 79% of CureSight-treated children achieving 2 or more lines of improvement, versus 61% in the patching group. CureSight also demonstrated significant improvement in stereoacuity and binocular VA, an important distinction, as Luminopia’s pivotal RCT did not show a significant stereoacuity benefit. It is worth noting, however, that the patching group in this study showed an essentially identical stereoacuity improvement of 0.40 log arcseconds. Adherence was 91% for CureSight versus 83% for patching. Wygnanski-Jaffe et al.8 followed the original RCT patients for one year after treatment stopped, with no additional amblyopia treatment permitted. VA gains were fully maintained at 12 weeks post-treatment with no regression. At one year, children lost less than one line from their end-of-treatment peak but retained approximately two full lines of improvement compared to baseline, a residual gain that remained statistically significant (p<0.0001). Stereoacuity and binocular VA gains were similarly maintained, and amblyopia recurrence occurred in only 5 of 27 patients at the one-year mark.

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