IMA-MODE: Multimodal Ophthalmic Imaging

Sponsor

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

Overall Status

Recruiting

CT.gov ID

NCT04129021

Collaborator

(none)

1,200

Enrollment

Location

Arm

47.5

Anticipated Duration (Months)

25.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Knowledge of the pathogenesis of ocular conditions, a leading cause of blindness, has benefited greatly from recent advances in ophthalmic imaging. However, current clinical imaging systems are limited in resolution, speed, or access to certain structures of the eye.

The use of a high-resolution imaging system improves the resolution of ophthalmoscopes by several orders of magnitude, allowing the visualization of many microstructures of the eye: photoreceptors, vessels, nerve bundles in the retina, cells and nerves in the cornea.

The use of a high-speed acquisition imaging system makes it possible to detect functional measurements such as the speed of blood flow. The combination of data from multiple imaging systems to obtain multimodal information is of great importance for improving the understanding of structural changes in the eye during a disease.

The purpose of this project is to observe structures that are not detectable with routinely used systems.

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 Corneal Dystrophy Keratoconus Dry Eye Trauma	Device: High-resolution retinal imaging through adaptive optics Device: High-resolution retinal imaging through holographic systems	N/A

Detailed Description

The goal of the project is the capture and analysis of images with the IMA-MODE systems, in order to evaluate the performance of these systems compared to the existing clinical imaging devices used at the National Hospital of Ophthalmology.

This project should identify the best techniques to image the eye, and select the most promising techniques to evolve towards a possible development of a medical device.

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:

High Resolution and High Speed Multimodal Ophthalmic Imaging

Actual Study Start Date :

Jul 15, 2019

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High-resolution retinal imaging through adaptive optics High-resolution retinal imaging through adaptive optics, full field OCT and holographic systems	Device: High-resolution retinal imaging through adaptive optics The protocol consists of performing retinal imaging using full-field optical coherence tomography. 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. Device: High-resolution retinal imaging through holographic systems The protocol consists of performing retinal imaging using a laser Doppler holography. For each system, 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: High-resolution retinal imaging through adaptive optics

High-resolution retinal imaging through adaptive optics, full field OCT and holographic systems

Device: High-resolution retinal imaging through adaptive optics

The protocol consists of performing retinal imaging using full-field optical coherence tomography. 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.

Device: High-resolution retinal imaging through holographic systems

The protocol consists of performing retinal imaging using a laser Doppler holography. For each system, 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 of a structure of interest and measuring the short-term and long-term reproducibility of the data collected compared to routine systems [From date of inclusion until the date of last documented progression , assessed up to 5 years]
Obtain the visualization of a structure of interest or obtain a measurement that are not detectable with the systems used routinely by analyzing images with image analysis software dedicated by a multidisciplinary group including doctors and physicists, assisted by computer scientists 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.
Pregnant or lactating women
Participant unable to be followed throughout the study
Vulnerable people
Subjects with predisposition to closure of the iridocorneal angle