Binocular eye tracking-based device is non-inferior to patching for the treatment of amblyopia

1. In a small randomized controlled trial, children with amblyopia who used a newly developed binocular dichoptic home device had similar visual acuity at 16 weeks as children who wore an eye patch.

2. Treatment adherence was significantly higher in the device group than in the patching group, 91% versus 83%.

Level of Evidence Classification: 1 (excellent)

Course of Study: Amblyopia is a common disorder in which the vision in one eye is impaired due to abnormalities during visual development, such as uneven refractive error or strabismus. It is traditionally treated with monocular therapy, punishing the dominant eye with patches or dilatation drops, but in recent years, several new binocular treatment methods have been developed. Children are presented with dichoptic (separate for each eye) images that are blurred in the dominant eye while stimulating the amblyopic eye. The purpose of this study was to evaluate the efficacy of such a device cure site compared to patching. A total of 103 patients with amblyopia were randomized to treatment with CureSight or patching for 16 weeks. At week 16, visual acuity in the amblyopic eye had improved significantly in both groups, 0.28±0.13 logMAR units in the cure-sight group and 0.23±0.14 in the patching group, meeting the non-inferiority baseline. Visual acuity improved by 2 lines or more in most patients in both groups. Stereoacuity, representing the use of both eyes, also improved significantly in both groups but did not differ between groups. Treatment adherence based on total treatment time was 91% in the CureSight group and 83% in the patching group. This small randomized trial convincingly demonstrated non-inferiority to patching, making the CureSight device the most rigorously studied of the recently developed binocular treatment systems and therefore a useful treatment option. made Although compliance with the device was significantly higher, it is more expensive and complicated than patching without showing superior visual acuity or stereotypical results at 16 weeks.

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Click to read the study in Ophthalmology.

Related reading: Recent advances in the screening and treatment of amblyopia

in deep [randomized controlled trial]: Children aged 4 to 9 years with a best visual acuity between 20/32 and 20/100 in the amblyopic eye at multiple centers in Israel were randomized 1:1, then treated between 2020 and 2022. The previous 16 weeks were excluded in the prescription. Children in the CureSight group watched videos on a computer through glasses that selectively obscured central vision in the dominant eye based on input from the eye tracker. CureSight treatment was 90 minutes, 5 days per week, while patching was 2 hours, 7 days per week. About half of the patients had previous patching, while half had never been treated. The primary noninferiority result was based on a modified intention-to-treat analysis, but the visual acuity difference was not significantly different in the per-protocol analysis. The difference in least-squares mean improvement in visual acuity in the amblyopic eye at 16 weeks between the CureSight and patching groups was 0.034 logMAR units, with a 90% confidence interval (CI) of -0.008 to 0.076, which was The default was less than zero. Inferior margin -0.10 logMAR units. The difference between groups in the change in stereotypy was 0, with a 95% CI of -0.27 to 0.27 (p = 0.76). The difference in improvement in binocular visual acuity at 16 weeks was also not significant.

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Photo: PD

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