Retinal Imaging by Adaptive Optics in Healthy Eyes and During Retinal and General Diseases

Completed

• Conditions: Retinal Dystrophies; Age-related Macular Degeneration; Arterial Hypertension; Diabetes; Traumatic Retinopathy; Toxic Retinopathies

• Registration Number: NCT01546181
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary

Using an adaptive optics imaging device, retinal structures are observed in healthy and diseased subjects.

Detailed Description

Most cases of severe visual loss in developed countries are due to retinal diseases affecting a specialized class of neurons, the photoreceptors. Currently available systems for retinal imaging in humans do not allow neuronal imaging at the cellular level, which is crucial to understand, diagnose and monitor retinal diseases. In recent years, adaptive optics (AO) fundus imaging has proven its capability to image individual photoreceptor cells in the human retina. This technology is now reaching technical maturation. A prototypic AO system (manufactured by Imagine Eyes) is currently in operation in a clinical setting (Clinical Investigation Center 503) and has proven its reliability to monitor single photoreceptors over time. Yet, the clinical evaluation of AO imaging is still in its infancy, and biomarkers issued from AO imaging have not been validated. The goal of the iPhot project is thus to optimize the process of AO imaging (from the implementation of novel technical solution to image processing and data analysis) in order to obtain morphological, quantitative and longitudinal information concerning retinal microstructures in humans. For instance, we will aim at detecting early photoreceptor damage during retinal dystrophies.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-03-02
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-07
• Primary Completion: 2017-06-15
• Study Completion: 2017-06-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

• over 10 years old

Exclusion Criteria

• ocular media opacities, unstable fixation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
photoreceptor density	01/12/2014	the variations of the density of photoreceptors over time will be evaluated

Trial Locations

Locations (1)

Clinical Investigation Center 503; 🇫🇷 Paris, France