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

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT01546181

Collaborator

(none)

300

Enrollment

Location

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Retinal Dystrophies Age-related Macular Degeneration Arterial Hypertension Diabetes Traumatic Retinopathy Toxic Retinopathies

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

Anticipated Enrollment :

300 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Controls subjects older than 10 years old, with no know ocular or general disease
Age-related macular degeneration
inherited retinal dystrophies
retinal trauma
toxic retinopathies
arterial hypertensive patients
diabetic patients
inflammatory diseases

Outcome Measures

Primary Outcome Measures

photoreceptor density [01/12/2014]
the variations of the density of photoreceptors over time will be evaluated

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

over 10 years old

Exclusion Criteria:

ocular media opacities, unstable fixation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Investigation Center 503	Paris		France	75012

Sponsors and Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Principal Investigator: Michel Paques, MD, PhD, Quinze-Vingts Hospital, Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut National de la Santé Et de la Recherche Médicale, France

ClinicalTrials.gov Identifier:

NCT01546181

Other Study ID Numbers:

C10-03
2010-A00492-37

First Posted:

Mar 7, 2012

Last Update Posted:

Feb 24, 2016

Last Verified:

Feb 1, 2016

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France

photoreceptors

retinal pigment epithelium

adaptive optics

Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2016