High Resolution, High-speed Multimodal Ophthalmic Imaging (IMA-MODE)

November 17, 2025 updated by: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

High Resolution and High Speed Multimodal Ophthalmic Imaging

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75012
        • Recruiting
        • Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visualization of a structure of interest and measuring the short-term and long-term reproducibility of the data collected compared to routine systems
Time Frame: 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.
From date of inclusion until the date of last documented progression , assessed up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Investigators

  • Principal Investigator: Michel PAQUES, Centre Hospitalier National d'Ophtalmologie des Quinze-Vints

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2019

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

August 19, 2019

First Submitted That Met QC Criteria

October 14, 2019

First Posted (Actual)

October 16, 2019

Study Record Updates

Last Update Posted (Estimated)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P19-03
  • 2019-A00942-55 (Registry Identifier: N° IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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