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

March 4, 2024 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

256

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75012
        • Clinical Investigation Center 503

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

controls and patients with any kind of retinal alteration

Description

Inclusion Criteria:

  • over 10 years old

Exclusion Criteria:

  • ocular media opacities, unstable fixation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
diabetic patients
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
inflammatory diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
photoreceptor density
Time Frame: 01/12/2014
the variations of the density of photoreceptors over time will be evaluated
01/12/2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

June 15, 2017

Study Completion (Actual)

June 15, 2017

Study Registration Dates

First Submitted

March 2, 2012

First Submitted That Met QC Criteria

March 6, 2012

First Posted (Estimated)

March 7, 2012

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C10-03
  • 2010-A00492-37 (Registry Identifier: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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