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Идёт набор NCT07577219

Vision Rehabilitation Training With Multimodal Feedback in Central Vision Loss

Без фазы С лечением Low Vision Central Visual Impairment Macular Degeneration

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: eccentric viewing training with biofeedback.
Кому может быть актуально
Состояния в реестре: Low Vision, Central Visual Impairment, Macular Degeneration. Базовые параметры: от 14 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

Central vision loss from macular degeneration creates blind spots that impair reading, face recognition, and navigation. Individuals must learn to use peripheral vision, requiring retraining of eye movements. Our preliminary research using high-speed eye tracking demonstrated that people with larger scotomas have impaired eye movement control, and that single-session visual feedback training showed limited immediate benefit, though combining feedback types showed promise. This study will evaluate whether extended binocular training (5 weekly sessions) with multimodal feedback improves eye movement control in 8-15 participants with bilateral central vision loss. Unlike conventional monocular rehabilitation systems, our approach trains both eyes simultaneously using real-time visual and auditory feedback during saccadic and smooth pursuit tasks. Participants will receive gaze-contingent scotoma awareness feedback, preferred retinal locus feedback, and auditory cues while performing eye tracking exercises. Primary outcomes include saccadic accuracy (latency, landing error, amplitude) and smooth pursuit parameters (gain, tracking accuracy). Secondary outcomes include contrast sensitivity and self-reported visual function. Success could establish an evidence base for accessible home-based training using virtual reality technology, potentially benefiting millions with macular degeneration.

Вмешательства

  • Поведенческое eccentric viewing training with biofeedback
    Participants will complete 5 weekly training sessions (approximately 60 minutes each) performing eye movement exercises while receiving real-time multimodal feedback. Training includes: Saccadic Training: Visually-guided saccades to targets appearing at randomized locations with instructions to use peripheral (inferior) retinal locus. Targets shift horizontally, vertically, and obliquely to train all saccadic directions. Smooth Pursuit Training: Circular pursuit of moving targets at 2.6°/s in

Первичные конечные точки

  • Change in Saccadic Accuracy (Landing Error) [Срок оценки: At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )]
Вторичные конечные точки (6)
  • Change in Saccadic Latency [Срок оценки: At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )]
  • Change in Smooth Pursuit Gain [Срок оценки: At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )]
  • Change in Number of Catch-up Saccades During Pursuit [Срок оценки: At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )]
  • Change in Contrast Sensitivity Function [Срок оценки: Baseline, Post-training (Week 6)]
  • Change in Fixation Stability [Срок оценки: Baseline, Post-training (Week 6)]
  • Change in Vision Related Quality of Life [Срок оценки: At First study visit - Baseline, at last training session - week 5, and post training (week 11 )]

Критерии участия

Критерии включения

Bilateral central scotomas confirmed via computerized tangent screen Visual acuity between 20/60 and 20/200 (0.5 - 1.00 logMAR) in either eye Stable central vision loss (no change in visual acuity >0.2 logMAR in past 6 months) Age 14 years or older, with diagnosis of macular disease Normal cognitive function (Mini-Mental State Examination score ≥24) Ability to provide informed consent and complete study visits No major hearing loss Fluent in English

Критерии исключения

Unstable ocular disease (e.g., ongoing treatments and/or injections) Peripheral vision loss of less than 40 degrees Conditions affecting oculomotor control independent of CVL

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • New England College of Optometry — Boston

Идентификаторы

NCT: NCT07577219 · Saccades 2.0

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗