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Идёт набор NCT05355415

Adaptive Optics Imaging of Outer Retinal Diseases

— Наблюдательное Retinal Degeneration Age-Related Macular Degeneration Retinitis Pigmentosa Hydroxychloroquine Retinopathy

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: Adaptive optics imaging.
Кому может быть актуально
Состояния в реестре: Retinal Degeneration, Age-Related Macular Degeneration, Retinitis Pigmentosa, Hydroxychloroquine Retinopathy. Базовые параметры: от 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The objective of the study is to collect adaptive optics (AO) retinal images from human subjects with outer retinal diseases (diseases of the outer retina including photoreceptor, retinal pigment epithelium (RPE), basement membrane or choroidal pathologies) to develop new diagnostic methods, biomarkers, and clinical endpoints.

Подробное описание

Objective: The objective of the study is to collect adaptive optics (AO) retinal images from human subjects with outer retinal diseases (diseases of the outer retina including photoreceptor, retinal pigment epithelium (RPE), basement membrane or choroidal pathologies) to develop new diagnostic methods, biomarkers, and clinical endpoints.

Study Population: Up to fifty (50) healthy volunteers without eye disease (Cohort 1) and up to fifty (50) affected participants with any type of outer retinal disease (Cohort 2) will be enrolled.

Design: This is a longitudinal study protocol where participants will be imaged with investigational multimodal AO (mAO) retinal imaging systems that include optical coherence tomography (OCT) and scanning laser ophthalmoscopy (SLO) channels over three years. High resolution OCT and SLO videos will be collected while the instruments automatically detect and correct for image distortion caused by ocular aberrations. In general, videos of different retinal cellular structures will be acquired from several retinal locations using various imaging modes.

Outcome Measures: The primary outcomes for this protocol are development of new diagnostic methods and disease biomarkers, investigation of cellular morphological and functional changes due to various outer retinal diseases, and development of new AO clinical endpoints for novel therapies.

Вмешательства

  • Устройство Adaptive optics imaging
    Adaptive optics scanning laser ophthalmoscopy (AOSLO) and adaptive optics - optical coherence tomography (AO-OCT) retinal imaging

Первичные конечные точки

  • Photoreceptor (PR) density [Срок оценки: PR density will be calculated once at the AO imaging session in which PRs are the target.]
  • Retinal pigment epithelial (RPE) cell density [Срок оценки: RPE cell density will be calculated once at the AO imaging session in which RPE cells are the target.]
  • RPE cell organelle motility [Срок оценки: RPE motility will be calculated once at the AO imaging session in which RPE cells are the target. For the reproducibility portion of the study, RPE organelle motility will be quantified three times separated by 1-2 weeks.]
  • PR cell function [Срок оценки: PR function will be calculated once at the AO imaging session in which PR cells are stimulated. For the reproducibility portion of the study, PR cell function will be quantified three times separated by 1-2 weeks.]

Критерии участия

Критерии включения

  • Are 21 years of age or older,
  • Have the ability to cooperate with instructions during adaptive optics imaging (similar to instructions given during a clinical eye exam),
  • Have the ability to understand and sign an informed consent. (Non-English speaking participants will not be enrolled into the study), and
  • Have been diagnosed with outer retinal disease or condition (Cohort 2).

Критерии исключения

  • Have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity),
  • Have visual correction outside of the range +4 diopters (D) to -8 D,
  • Have a history of adverse reaction to mydriatic drops,
  • Have a predisposition to (i.e., narrow iridocorneal angle) or any history of acute angle closure glaucoma (AACG), or
  • Are working under the direct supervision of Drs. Hammer, Cukras and Liu, or any of the NIH/NEI AIs.

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

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 2 центра
  • NIH Clinical Center — Bethesda
  • Food and Drug Administration — Silver Spring

Идентификаторы

NCT: NCT05355415 · 2019-CDRH-074

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗