Adaptive Optics Retinal Imaging

Status Recruiting

Clinical Trial Summary

The objective of the study is to collect and assess adaptive optics (AO) retinal images from human subjects in support of projects to demonstrate, advance, and enhance clinical use of AO technology.

Clinical Trial Description

Objective: The objective of the study is to collect and assess adaptive optics (AO) retinal images from human subjects in support of projects to demonstrate, advance, and enhance clinical use of AO technology. Study Population: Fifty (50) healthy volunteers without eye disease and thirty (30) subjects with primary open angle glaucoma (POAG) will be enrolled. Design: This is an interventional study protocol where participants will be imaged with investigational multimodal AO retinal imaging systems that include optical coherence tomography (OCT) and scanning laser ophthalmoscopy (SLO) channels. 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 structures will be acquired from several retinal locations using various imaging modes. Outcome Measures: The primary outcomes for this protocol are qualitative and quantitative assessment of the AO images and investigation of the cellular morphological and physiological changes due to glaucoma. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05370287
Study type	Interventional
Source	Food and Drug Administration (FDA)
Contact	Daniel X Hammer, Ph.D.
Phone	301-796-9320
Email	daniel.hammer@fda.hhs.gov
Status	Recruiting
Phase	N/A
Start date	January 22, 2018
Completion date	September 30, 2026

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