Trial of Vision Therapy for Intermittent Exotropia

Официальное название

A Pilot Randomized Trial Evaluating Short-Term Effectiveness of Vision Therapy in Children With Intermittent Exotropia

Обзор

The main objective of this randomized trial comparing vision therapy to observation is to determine the short-term effectiveness of vision therapy on distance intermittent exotropia control. The results will help determine whether to proceed to a full-scale, long-term randomized trial.

Подробное описание

Vision therapy (VT) is a commonly prescribed treatment for children with intermittent exotropia (IXT). The effectiveness of VT as a treatment modality for children with IXT is unknown because previous studies have largely limited observational or retrospective case series without comparison groups. The objective of this multi-centered pilot randomized trial of VT for IXT compared to observation is to 1) determine the short-term effectiveness of VT on distance intermittent exotropia and 2) determine the feasibility of recruitment and retention of children aged 8 to 16 years old with IXT to participate in a randomized trial of 20 weeks of in-office VT. The results of this trial will provide the needed information to plan and conduct a large-scale randomized trial to determine short-term and long-term effectiveness of VT for IXT in children, with the full-scale randomized trial helping to fill in the gaps in scientific knowledge concerning VT as a treatment for IXT.

Вмешательства

• Другое Vision Therapy
  20 consecutive weeks of office-based vision therapy with home therapy that aim to improve the participant's vergence skills, accommodative skills, and sensory fusion.

Первичные конечные точки

• Mean Distance Control Score [Срок оценки: 21 weeks]

Вторичные конечные точки (2)

• No Spontaneous Tropia [Срок оценки: 21 weeks]
• Change in Distance Control [Срок оценки: 21 weeks]

Критерии участия

Major Inclusion Criteria-

• Age 8 - 16 years
• Intermittent exotropia meeting all of the following:

• Distance exodeviation of 15∆ to 35∆ by prism alternating cover test (PACT)
• IXT, exophoria, or orthophoria at near
• Near exodeviation that does not exceed the distance exodeviation by more than 10∆
• Mean distance control score of 2 points or more with at least one measure being 3 points or higher
• Mean near control score less than 5 points
• Random dot stereopsis of 200" or better on Preschool Randot Stereotest
• Willingness to accept randomization and no plan to relocate in the next 6 months

Major Exclusion Criteria-

• Treatment for IXT or amblyopia (other than refractive correction) within 3 months prior to enrollment
• Office-based vision therapy for IXT within 6 months prior to enrollment
• Prior office-based vision therapy for IXT of ≥10 sessions
• Prior strabismus, intraocular, or refractive surgery (including BOTOX injection)

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

Простое слепое

Основная цель

Лечение

Центры проведения

США · 6 центров

• University of Alabama in Birmingham — Birmingham
• Southern California College of Optometry at Marshall B. Ketchum University — Fullerton
• Stanford University — Stanford
• Ohio State University — Columbus
• Salus University — Philadelphia
• Southern College of Optometry — Memphis

Идентификаторы

NCT: NCT04487249 · 20-08

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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