Binocular Amblyopia Treatment

Обзор

To evaluate the effectiveness of enhanced binocular amblyopia treatments in achieving a more complete and stable recovery.

Подробное описание

To date, all studies of contrast-rebalanced binocular amblyopia treatment games used the same 10% per day contrast-increment that was designed for short-term intervention studies lasting 1-4 weeks; i.e., after 18 days of successful game play, both eyes viewed 100% contrast (no contrast-rebalancing).This study will investigate two alternative protocols designed to extend the game treatment period beyond 4 weeks to allow for more complete recovery of visual acuity. The new protocols will be compared with the original 10% contrast-increment game protocol in an 8-week 3-arm RCT to determine whether one or both of the new protocols is more effective than the current 10% increment.

Based on pilot data, we expect about 40% of amblyopic children to achieve normal visual acuity in 8 weeks. In an effort to also promote recovery of binocular vision, children who attain ≤0.4 logMAR at 8 weeks will be enrolled in stereoacuity training at the 8-week visit for the next 4 weeks. Children with residual amblyopia (BCVA \>0.4 logMAR) at the 8-week visit will be provided with dichoptic movies for additional amblyopia treatment for another 4 weeks.

Вмешательства

• Другое Binocular games for treatment of amblyopia
  playing binocular games on a tablet platform 1 hour per day 5 days per week with reduced contrast for the fellow eye and high contrast for the amblyopic eye

Первичные конечные точки

• Change in visual acuity of the amblyopic eye [Срок оценки: baseline vs 8 weeks]

Вторичные конечные точки (3)

• Change in visual acuity of the amblyopic eye [Срок оценки: baseline vs 2, 4, 6, and 12 weeks]
• Change in stereoacuity [Срок оценки: baseline vs 2, 4, 6, 8, 12 weeks]
• Change in suppression [Срок оценки: baseline vs 2, 4, 6, 8, 12 weeks]

Критерии участия

Критерии включения

• age 4-10 y
• male and female
• strabismic, anisometropic, or combined mechanism amblyopia
• amblyopic eye best-corrected visual acuity 0.3-0.8 logMAR
• fellow eye best-corrected visual acuity ≤0.1 logMAR
• interocular visual acuity difference ≥0.3 logMAR
• wearing glasses (if needed) for 8 weeks or no change visual acuity with glasses at 2 visits

• 4 weeks apart.
• child's ophthalmologist and family must be willing to forgo patching treatment during the 12-week study period
• parent's informed consent
• child must demonstrate understanding and ability to play binocular games

Критерии исключения

• prematurity ≥8 weeks
• coexisting ocular or systemic disease
• developmental delay
• strabismus >5pd
• any binocular amblyopia treatment in the past 3 months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Retina Foundation of the Southwest — Dallas

Публикации

• Jost RM, Kelly KR, Birch EE. Risk of recurrence after cessation of dichoptic, binocular treatment of amblyopia. J AAPOS. 2023 Oct;27(5):298-300. doi: 10.1016/j.jaapos.2023.06.009. Epub 2023 Aug 23. PMID 37619861
• Jost RM, Kelly KR, Hunter JS, Stager DR Jr, Luu B, Leffler JN, Dao L, Beauchamp CL, Birch EE. A randomized clinical trial of contrast increment protocols for binocular amblyopia treatment. J AAPOS. 2020 Oct;24(5):282.e1-282.e7. doi: 10.1016/j.jaapos.2020.06.009. Epub 2020 Oct 9. PMID 33045374

Идентификаторы

NCT: NCT03288948 · 062010-105 · R01EY022313

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗