Bimodal and Coaxial High Resolution Ophtalmic Imaging

Not Applicable

Recruiting

• Conditions: Retinitis Pigmentosa; Macular Edema; Vascular Inflammation; Maculopathy, Age Related; Retinal Degeneration; Diabetes; Macular Dystrophy; Glaucoma; Retinal Detachment; Hypertension
• Interventions: Other: Bimodal high resolution imaging of the retina

• Registration Number: NCT04620876
• Lead Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

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.

Detailed Description

The goal of the project is the capture and analysis of images with AOSLO system, in order to evaluate the performance of this system compared to OCT imaging devices and existing Adaptive Optics used at National Hospital of Ophthalmology.

Study Timeline

• Study Start: 2019-10-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-04
• Study First Submitted QC: 2020-11-04
• Last Update Submitted: 2020-11-04
• Study First Posted: 2020-11-09
• Last Update Posted: 2020-11-09
• Primary Completion: 2023-10-01
• Study Completion: 2024-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

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

Exclusion Criteria

• 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bimodal and coaxial high resolution imaging of the retina	Bimodal high resolution imaging of the retina	Optical coherence tomography and Scanning laser ophthalmoscope system using adaptive optics (AO-SLO-OCT)

Primary Outcome Measures

Name	Time	Method
Visualization and image analysis of a structure of interest	From date of inclusion until the date of last documented progression , assessed up to 5 years	The visualization of the structure of interest in at least one area of the image will be considered the main criterion of success.

Trial Locations

Locations (1)

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts; 🇫🇷 Paris, France