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

This study is currently recruiting participants.
Verified March 2012 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01546181
First received: March 2, 2012
Last updated: May 2, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition
Retinal Dystrophies
Age-related Macular Degeneration
Arterial Hypertension
Diabetes
Traumatic Retinopathy
Toxic Retinopathies

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • photoreceptor density [ Time Frame: 01/12/2014 ] [ Designated as safety issue: No ]
    the variations of the density of photoreceptors over time will be evaluated


Estimated Enrollment: 300
Study Start Date: October 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

controls and patients with any kind of retinal alteration

Criteria

Inclusion Criteria:

  • over 10 years old

Exclusion Criteria:

  • ocular media opacities, unstable fixation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546181

Contacts
Contact: michel paques, MD, PhD +33 1 40 02 14 15 michel.paques@gmail.com

Locations
France
Clinical Investigation Center 503 Recruiting
Paris, France, 75012
Contact: michel paques, MD, PhD     +33 1 40 02 14 15     michel.paques@gmail.com    
Principal Investigator: michel Paques, MD, PhD            
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
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01546181     History of Changes
Other Study ID Numbers: C10-03, 2010-A00492-37
Study First Received: March 2, 2012
Last Updated: May 2, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
photoreceptors
retinal pigment epithelium
adaptive optics

Additional relevant MeSH terms:
Hypertension
Macular Degeneration
Retinal Diseases
Retinal Dystrophies
 Vascular Diseases
Cardiovascular Diseases
Retinal Degeneration
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013