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Clinical Trials/NCT01546181
NCT01546181CompletedNot Applicable

Observational, Follow-up Study of Adaptive Optics Retinal Imaging in Controls and During Retinal or General Diseases

Institut National de la Santé Et de la Recherche Médicale, France1 site in 1 country256 target enrollmentStarted: October 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
256
Locations
1
Primary Endpoint
photoreceptor density

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
10 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • over 10 years old

Exclusion Criteria

  • ocular media opacities, unstable fixation

Outcomes

Primary Outcomes

photoreceptor density

Time Frame: 01/12/2014

the variations of the density of photoreceptors over time will be evaluated

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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