Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease

Обзор

This study will perform a prospective, longitudinal analysis of clinical and imaging findings from normal controls and subjects with retinal vascular disease to better define the diagnostic imaging criteria that signify change in disease stage. This includes disease progression in early stages of disease or disease regression with appropriate standard-of-care treatment.

Подробное описание

The objective of this study is to perform a prospective, longitudinal analysis of clinical and imaging findings from normal controls and subjects with retinal vascular disease to better define the diagnostic imaging criteria that signify change in disease stage. This includes disease progression in early stages of disease or disease regression with appropriate standard-of-care treatment.

Subjects will be identified from healthy subjects (seen for screening eye exams) and diseased subjects undergoing standard-of-care treatment or screening at eye clinic locations. The study population will include subjects with retinal vascular disease including but not limited to diabetic retinopathy, hypertension, retinal vein/arterial occlusion, and macular degeneration. Subjects who are enrolled will undergo non-invasive, minimal risk, FDA approved diagnostic imaging procedures to identify vascular changes.

The study methods will include retrospective review and collection of clinically approved imaging data that is obtained through standard-of-care methods for subjects who meet inclusion and exclusion criteria. Subjects who are identified in this manner will be asked to participate in a prospective study by each clinical study site.

The study end-points include the correlation of diagnostic imaging findings from Optical Coherence Tomography (OCT) based images with fundus photographs, clinical disease stage and visual acuity.

Вмешательства

• Устройство Swept-Source (SS) OCT Angiography
  Non-invasive, minimal risk, ocular imaging study
• Устройство Spectral-Domain (SD) OCT Angiography
  Non-invasive, minimal risk, ocular imaging study
• Устройство Fundus Imaging
  Non-invasive, minimal risk, ocular imaging study
• Устройство Axial Length Measurement Device
  Non-invasive, minimal risk, ocular imaging study

Первичные конечные точки

• Correlation of Imaging [Срок оценки: 5 years]

Критерии участия

Критерии исключения

• Both subjects with diseases and controls:
• Children (age<18)
• Pregnant females
• Developmentally delayed subjects
• Subjects unable to provide informed consent
• Inability to cooperate with tests and study instructions
• Images with motion artifact or signal strength < 7
• History of glaucoma
• History of age-related macular degeneration
• History of any visually significant eye disease
• History of proliferative diabetic retinopathy
• History of any inflammatory disease
• History of heart disease
• History of thyroid disease.
• Additional criteria for controls:
• History of any type of Diabetes Mellitus
• History of any type of Hypertension

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

Простое слепое

Основная цель

Скрининг

Центры проведения

США · 1 центр

• Wilmer Eye Institute — Baltimore

Идентификаторы

NCT: NCT04505618 · IRB00276904 · R01EY030564

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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