AOSLO-OCT: Bimodal and Coaxial High Resolution Ophtalmic Imaging

Sponsor

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts (Other)

Overall Status

Recruiting

CT.gov ID

NCT04620876

Collaborator

(none)

1,200

Enrollment

Location

Arm

60.5

Anticipated Duration (Months)

19.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinitis Pigmentosa Maculopathy, Age Related Macular Dystrophy Macular Edema Retinal Detachment Retinal Degeneration Glaucoma Vascular Inflammation Hypertension Stroke Diabetes	Other: Bimodal high resolution imaging of the retina	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Bimodal and Coaxial High Resolution Ophtalmic Imaging

Actual Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bimodal and coaxial high resolution imaging of the retina Optical coherence tomography and Scanning laser ophthalmoscope system using adaptive optics (AO-SLO-OCT)	Other: Bimodal high resolution imaging of the retina 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.

Arm

Intervention/Treatment

Experimental: Bimodal and coaxial high resolution imaging of the retina

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

Other: Bimodal high resolution imaging of the retina

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.