NCT05355415

Adaptive Optics Imaging of Outer Retinal Diseases

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Food and Drug Administration (FDA) · Federal
• Sex: All
• Age: 21 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Retinal Degeneration
• Age-Related Macular Degeneration
• Retinitis Pigmentosa
• Hydroxychloroquine Retinopathy
• Usher Syndromes
• Late-Onset Retinal Degeneration
• Cone Dystrophy
• Cone Rod Dystrophy
• Rod Cone Dystrophy
• Rod Dystrophy

Interventions

Type	Name	Description
DEVICE	Adaptive optics imaging	Adaptive optics scanning laser ophthalmoscopy (AOSLO) and adaptive optics - optical coherence tomography (AO-OCT) retinal imaging

Timeline

• Start date: 2021-08-27
• Primary completion: 2026-08-27
• Completion: 2026-08-27
• First posted: 2022-05-02
• Last updated: 2025-04-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study