Bimodal and Coaxial High Resolution Ophtalmic Imaging

NCT04620876 | Unknown

• 2 other identifiers: P16-022016-A00704-47
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The knowledge of the pathogenesis of retinal affections, a major cause of blindness, has greatly benefited from recent advances in retinal imaging. However, optical aberrations of the ocular media limit the resolution that can be achieved by current techniques. The use of an adaptive optics system improves the resolution of ophthalmoscopes by several orders of magnitude, allowing the visualization of many retinal microstructures: photoreceptors, vessels, bundles of nerve fibers. Recently, the development of the coupling of the two main imaging techniques, the Adaptive Optics Ophthalmoscope with Optical Coherence Tomography, enables unparalleled three-dimensional in vivo cell-scale imaging, while remaining comfortable for the patients. The purpose of this project is to evaluate the performance of this system for imaging micrometric retinal structures.

Conditions

Retinitis Pigmentosa; Maculopathy, Age Related; Macular Dystrophy; Macular Edema; Retinal Detachment; Retinal Degeneration; Glaucoma; Vascular Inflammation; Hypertension; Stroke; Diabetes

Outcome Measures

Primary Outcomes (1)

• Visualization and image analysis of a structure of interest

  The visualization of the structure of interest in at least one area of the image will be considered the main criterion of success.

  From date of inclusion until the date of last documented progression , assessed up to 5 years

Study Arms (1)

Bimodal and coaxial high resolution imaging of the retina

EXPERIMENTAL

Optical coherence tomography and Scanning laser ophthalmoscope system using adaptive optics (AO-SLO-OCT)

Other: Bimodal high resolution imaging of the retina

Interventions

Bimodal high resolution imaging of the retina OTHER

The protocol consists of performing an Optical coherence tomography and Scanning laser ophthalmoscope system using adaptive optics (AO-SLO-OCT).The participant is asked to put his forehead against the temple supports and his chin on a chin rest. The subject will be asked to fix a test pattern in the form of a cross. The pattern is positioned according to the desired eccentricity with respect to the fovea. The actual acquisition lasts a few seconds, possibly repeated to cover the field of the desired eye. The acquisition protocol depends on the subjects, their pathology and the system used; the area examined will be modified on a case by case basis. The total duration of each exam can be estimated at less than half an hour, with frequent breaks.

Bimodal and coaxial high resolution imaging of the retina

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People over 18
• Patient with a pathology affecting the eye or healthy volunteer
• Participant who signed the consent
• Beneficiaries of the health insurance

You may not qualify if:

• Patients with a history of photosensitivity.
• Patients who have just received a photodynamic therapy treatment
• Patients taking drugs with photosensitivity as a side effect.
• Persons with pacemakers or other implanted electronic medical device
• Patients with viral conjunctivitis or any other infectious disease.
• Patients with skin lesions on the neck or forehead
• Patients at high risk of damage from optical radiation, such as aphakic patients, or patients with decreased sensitivity to light due to fundus disease.
• Participant unable to be followed throughout the study
• Advanced cataract or severe opacities in the anterior segment of the eye.

Sponsors & Collaborators

• Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts: lead

Study Sites (1)

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Retinitis Pigmentosa; Macular Degeneration; Macular Edema; Retinal Detachment; Retinal Degeneration; Glaucoma; Hypertension; Stroke; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ocular Hypertension; Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Michel PAQUES

  Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hayet Serhane

CONTACT

0140021144; hserhane@15-20.fr

Tania Rilcy

CONTACT

0140021126; trilcy@15-20.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 9, 2020
• Study Start: October 1, 2019
• Primary Completion: October 1, 2023
• Study Completion: October 15, 2024
• Last Updated: November 9, 2020

Record last verified: 2020-11

Locations

FR (1)