Home-based Vision Therapy
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: Virtual-reality convergence training game.
- Кому может быть актуально
- Состояния в реестре: Convergence Insufficiency. Базовые параметры: 18 лет — 80 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Home-based Treatment of Binocular Eye Dysfunction in Veterans With Traumatic Brain Injury
Обзор
Post-concussive vision symptoms affect many Veterans who have experienced traumatic brain injury (TBI). One common issue is trouble with near vision, a problem that may persist long after the acute injury. Double vision or difficulty focusing on close objects can affect reading and depth perception. Poor reading can interfere with academic or work performance, and loss of near focusing can affect jobs that require fine motor tasks like machining and electrical work. Even having trouble using a smartphone can have a substantial impact on both work and social function. Near vision impairment after TBI is not well understood, and treatments are limited. The goal of this project is to investigate novel virtual-reality assessments and training games to improve the near vision diagnosis and home-based rehabilitation. Restoring normal near vision function could have a large impact on the fulfillment of Veterans' educational, career, and overall life goals.
Вмешательства
- Другое Virtual-reality convergence training game
The participant plays a custom virtual-reality game that is designed to train convergence.
Первичные конечные точки
- Vergence Capacity (VR-NPC) [Срок оценки: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)]
- System Usability Scale (SUS) [Срок оценки: At completion of active treatment block (six-weeks duration)]
- Simulator Sickness Questionnaire (SSQ) [Срок оценки: At completion of active treatment block (six-weeks duration)]
Вторичные конечные точки (10)
- Accommodation [Срок оценки: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)]
- Dynamic Vergence [Срок оценки: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)]
- Stereoacuity [Срок оценки: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)]
- VR Word Reading: Word Accuracy Score [Срок оценки: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)]
- VR Word Reading: Reading Speed Score [Срок оценки: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)]
- WIAT Word Reading Tests: Word Accuracy Score [Срок оценки: At study onset, At completion of Block 2 (six weeks duration)]
- WIAT Word Reading Test: Word Fluency Score [Срок оценки: At study onset, At completion of Block 2 (six weeks duration)]
- WIAT Oral Reading Fluency and Comprehension Test: Oral Reading Accuracy Score [Срок оценки: At study onset, At completion of Block 2 (six weeks duration)]
- WIAT Oral Reading Fluency and Comprehension Test: Oral Reading Fluency Score [Срок оценки: At study onset, At completion of Block 2 (six weeks duration)]
- Convergence Insufficiency Symptom Survey (CISS) [Срок оценки: At study onset, At completion of Block 1 (six weeks duration), At completion of Block 2 (six weeks duration)]
Критерии участия
Критерии включения
- U.S. Military Veteran
- Place of residence within driving distance of Cleveland, OH
- Clinical eye exam within 6 months prior to enrollment and since the most recent TBI (if applicable) and the onset of near vision symptoms (if applicable)
- Best-corrected visual acuity 20/25 or better in each eye
- Convergence insufficiency (VR-NPC < 32 deg)
Критерии исключения
- Neurological condition other than TBI that would affect convergence
- History of strabismus, amblyopia, or other binocular vision issues prior to TBI
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland
Идентификаторы
NCT: NCT06886737 · N5317-R