High Resolution, High-speed Multimodal Ophthalmic Imaging

NCT ID: NCT04129021

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-03
• Study Completion Date: 2027-07-31

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

High-resolution retinal imaging through adaptive optics

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

Group Type: EXPERIMENTAL

High-resolution retinal imaging through adaptive optics

Intervention Type: DEVICE

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.

High-resolution retinal imaging through holographic systems

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel PAQUES

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier National d'Ophtalmologie des Quinze-Vints

Locations

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Nabil BROUK

Role: CONTACT

nbrouk@15-20.fr

+33 140021144

Azedine DJABALI

Role: CONTACT

Adjabali@15-20.fr

+33 140021126

Facility Contacts

Michel PAQUES, PU-PH

Role: primary

mpaques@15-20.fr

01 40 02 14 15

References

Paques M, Norberg N, Chaumette C, Sennlaub F, Rossi E, Borella Y, Grieve K. Long Term Time-Lapse Imaging of Geographic Atrophy: A Pilot Study. Front Med (Lausanne). 2022 Jun 22;9:868163. doi: 10.3389/fmed.2022.868163. eCollection 2022.

Reference Type: DERIVED

PMID: 35814763 (View on PubMed)

Other Identifiers

2019-A00942-55

Identifier Type: REGISTRY

Identifier Source: secondary_id

P19-03

Identifier Type: -

Identifier Source: org_study_id