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Binocular Home Treatment for Amblyopia: Gains Stable for One Year.
Wygnanski-Jaffe, Tamara; Moshkovitz, Avital; Kushner, Burton J; Belkin, Michael; Yehezkel, Oren.
Afiliación
  • Wygnanski-Jaffe T; Goldschleger Eye Institute, Sheba Medical Center (T.W.-J.), Tel Hashomer, Israel; Sackler Faculty of Medicine, Tel-Aviv University (T.W.-J., M.B.), Tel-Aviv, Israel.
  • Moshkovitz A; NovaSight Ltd. (A.M., O.Y.), Airport City, Israel.
  • Kushner BJ; Department of Ophthalmology and Visual Sciences, University of Wisconsin (B.J.K.), Madison, Wisconsin, USA.
  • Belkin M; Sackler Faculty of Medicine, Tel-Aviv University (T.W.-J., M.B.), Tel-Aviv, Israel; Goldschleger Eye Research Institute, Sheba Medical Center (M.B.), Tel Hashomer, Israel.
  • Yehezkel O; NovaSight Ltd. (A.M., O.Y.), Airport City, Israel. Electronic address: oren.yehezkel@gmail.com.
Am J Ophthalmol ; 262: 199-205, 2024 06.
Article en En | MEDLINE | ID: mdl-38360334
ABSTRACT

PURPOSE:

To report the long-term outcomes of a noninferiority randomized controlled trial (RCT) with a binocular eye-tracking-based home treatment (CureSight; NovaSight, Ltd.) in patients with amblyopia.

DESIGN:

Prospective, multicenter, nonrandomized, long-term follow-up observational study of an RCT.

METHODS:

Forty-three children 4 to <9 years of age with anisometropic, small-angle strabismic, or mixed-mechanism amblyopia were initially treated for 16 weeks (NCT05185076) with CureSight. In this planned observational follow-up study, 38 patients with no additional amblyopia treatment were evaluated at 12 weeks post-treatment, and 27 were evaluated at 1-year post-treatment. The main outcome measures were visual acuity (VA), stereoacuity, and amblyopia recurrence at 12- and 52-week post-treatment.

RESULTS:

At 12-week post-treatment, improvement in amblyopic eye VA was maintained vs baseline (0.27 ± 0.14 logMAR, P< .0001), with no change vs the end-of-treatment visit (P > .05). At 1 year there was a partial reduction in the amblyopic eye VA gain of 0.085±0.1 logMAR compared to end-of-treatment (P = .001), but the residual gain of 0.20±0.14 logMAR compared to baseline was statistically significant (P < .0001). Gains in stereoacuity and binocular VA were maintained vs baseline at both 12-weeks and 1-year post-treatment (P < .0001), with no change vs end-of-treatment (P > .05). Amblyopia recurrence (a worsening of ≥2 logMAR levels compared with end-of-treatment) occurred in 2/38 patients at 12-weeks post-treatment (5.3%), and in 5/27 patients at 1-year post-treatment (20.4%).

CONCLUSIONS:

VA and stereopsis gains following binocular treatment with CureSight were maintained at 1 year without additional treatment.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Visión Binocular / Agudeza Visual / Ambliopía Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies Límite: Child / Child, preschool / Female / Humans / Male Idioma: En Revista: Am J Ophthalmol Año: 2024 Tipo del documento: Article País de afiliación: Israel Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Visión Binocular / Agudeza Visual / Ambliopía Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies Límite: Child / Child, preschool / Female / Humans / Male Idioma: En Revista: Am J Ophthalmol Año: 2024 Tipo del documento: Article País de afiliación: Israel Pais de publicación: Estados Unidos