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Набор скоро начнётся NCT06848673

Natural History of MTBI-related Convergence Insufficiency & Effectiveness of Vision Therapy for MTBI-related CI

Фаза II С лечением Convergence Insufficiency

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: Office-Based Vergence/Accommodative Therapy with Movement (OBVAM).
Кому может быть актуально
Состояния в реестре: Convergence Insufficiency. Базовые параметры: 18 лет — 35 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
Список центров уточняется — проверьте первичный протокол.
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

PILOT CLINICAL TRIAL (PCT) of the Natural History of the Most Common MTBI-related Oculomotor Disorder Convergence Insufficiency & the Effectiveness of Vergence/Accommodative Therapy for MTBI-related Convergence Insufficiency

Обзор

The design of this project is a pilot study, a type of feasibility study conducted in preparation for subsequent RCTs that will assess the effectiveness of office-based vergence/accommodative therapy with movement (OBVAM) for mTBI-related convergence insufficiency.

Подробное описание

The design of this project is a pilot study, a type of feasibility study conducted in preparation for subsequent RCTs that will assess the effectiveness of interventions or therapies. In this application, we refer to this pilot and feasibility study as a pilot clinical trial (PCT). This feasibility PCT aims to identify potential challenges, logistical issues, and unforeseen complications. To do this, we will examine various feasibility aspects, including recruitment and retention, randomization, intervention protocols, outcome measures, ethical considerations, safety monitoring, resource availability, and stakeholder feedback. By conducting this PCT, we can test our procedures and gather preliminary data. The primary objectives of this feasibility PCT are to 1) Determine the feasibility of conducting future full-scale RCTs by evaluating the effectiveness of a novel vergence/accommodative/move (OBVAM) therapy program for young adults with mTBI-CI and 2) Better understand the progression and stability (i.e., natural history) of mTBI-CI over the 6 weeks following enrollment.

Вмешательства

  • Другое Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)
    Head and body movements are incorporated into some therapy procedures in Phases 3 and 4. Additional details are provided in the Overall Program Narrative. Participants undergoing office-based VAM therapy will be prescribed home therapy procedures including the HTS2 Home Vision Therapy System (https://htsvision.com/) thrice weekly to support their in-office VAM therapy. This software progressively increases fusional convergence and divergence demands, offers instant user feedback, and will allow

Первичные конечные точки

  • Clinical Composite Measure [Срок оценки: 6 weeks]
Вторичные конечные точки (2)
  • Comparison of the Change in the Near Point of Convergence (NPC) break and recovery value [Срок оценки: 6 weeks]
  • Comparison of the Change in Positive Fusional Vergence after 6 weeks between the Two Groups [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

  • • Age 18 to 35 years inclusive
  • Medical diagnosis of mTBI or concussion > 1 month ago and no longer than 6 months ago
  • Convergence Insufficiency Symptom (CISS score) ≥ 21
  • Best-corrected VA of 20/25 or better in both eyes at distance \& near
  • Willingness to wear refractive correction, if indicated
  • Random dot stereopsis of 500 arcsec or better (Randot Stereo Test)
  • Receded NPC of ≥6 cm
  • Insufficient PFV (< 15∆ or PFV blur point less than twice the near exophoria magnitude)
  • Wearing refractive correction for cycloplegic refractive errors of:
  • ≥ +1.25 D SE hyperopia or ≥ -1.00 D SE myopia in either eye
  • ≥ 1.25 D astigmatism in either eye, ≥ 1.00 D SE anisometropia
  • Astigmatism axis within ±10 degrees if magnitude is ≤1.00 D and within ±5 degrees if >1.00 D

Критерии исключения

  • • No previous treatment for CI
  • No previous diagnosis of CI from an ophthalmologist or optometrist
  • No medications known to affect accommodation or vergence
  • Investigator \& patient willing to forgo all other CI treatment other than that assigned by randomization

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06848673 · VR230111 · VR230111

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗