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Идёт набор NCT05150197

Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease

Без фазы С лечением Visual Field Defect, Peripheral

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: VisuALL, Humphrey Visual Field.
Кому может быть актуально
Состояния в реестре: Visual Field Defect, Peripheral. Базовые параметры: 4 лет — 21 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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Официальное название

Virtual Reality Visual Field Testing as an Alternative to Standard Automated Perimetry in Childhood Eye Disease

Обзор

The purpose of this study is to test a new way of measuring the peripheral vision (called a visual field test) using a device which can be worn as goggles rather than being a large instrument the patient must sit at. This new visual field test (called VisuALL) is an FDA-approved virtual reality system which has been used in adults and children. This study will compare the performance of the VisuALL to the standard testing for peripheral vision, which is called the Humphrey Visual Field (HVF) test. The study will recruit both healthy children, as well children and young adults who have eye conditions which require visual field testing as part of their standard care. The test will be performed on a day when the child or young adult already has a scheduled eye appointment as standard care. The test does not touch the eyes or require any eye drops to be given, and there is no known risk associated with the test itself. There may be a risk of loss of confidentiality. Participating in this study will require approximately 30 minutes, has no extra cost associated with it, and will be compensated by a parking pass for the day of the visit. There are no direct benefits for participants. Selected participants will be also be given training and then loaned a home VisuALL system to allow home visual field testing. If your child is selected, additional information would be provided.

Вмешательства

  • Устройство VisuALL
    Virtual Reality Visual Field Device
  • Устройство Humphrey Visual Field
    Standard of care Visual Field test

Первичные конечные точки

  • Mean deviation results of visual field parameters [Срок оценки: During office visit, approximately 30 minutes]
  • Pattern standard deviation results of visual field parameters [Срок оценки: During office visit, approximately 30 minutes]
  • Sensitivity results of visual field parameters [Срок оценки: During office visit, approximately 30 minutes]
Вторичные конечные точки (4)
  • Percent of times that scotomas were visualized as measured by visual field tests [Срок оценки: During office visit, approximately 30 minutes]
  • Percent of participants stating satisfaction as measured by questionnaire [Срок оценки: During office visit, approximately 5 minutes]
  • Percent of patients able to use VisuALL in-office testing as measured by patient observation [Срок оценки: During office visit, approximately 30 minutes]
  • Percent of patients able to use VisuALL home testing as measured by device reading [Срок оценки: During office visit, 30 minutes]

Критерии участия

Критерии включения

  • Patients must be at least four (4) years old
  • Cognitively normal (no developmental delay or syndrome)
  • Be able to tolerate wearing the virtual reality goggles for at least 10 minutes
  • Be able to provide informed consent of a parent/guardian (and assent if 12 years or older)
  • Do not have any ocular diseases that could interfere with the visual field testing

Критерии исключения

  • Developmental delay
  • Inability to obtain consent
  • Inability to understand English

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 1 центр
  • Duke University Medical Center — Durham

Публикации

  • Razeghinejad R, Gonzalez-Garcia A, Myers JS, Katz LJ. Preliminary Report on a Novel Virtual Reality Perimeter Compared With Standard Automated Perimetry. J Glaucoma. 2021 Jan 1;30(1):17-23. doi: 10.1097/IJG.0000000000001670. PMID 32941320
  • Montelongo M, Gonzalez A, Morgenstern F, Donahue SP, Groth SL. A Virtual Reality-Based Automated Perimeter, Device, and Pilot Study. Transl Vis Sci Technol. 2021 Mar 1;10(3):20. doi: 10.1167/tvst.10.3.20. PMID 34003954

Идентификаторы

NCT: NCT05150197 · Pro00109426

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗