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NCT Number: NCT04129021

High Resolution, 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.

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Key information

Conditions

Retinitis Pigmentosa Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Corneal Dystrophy Diabetes Diabetes Mellitus Dry Eye Dry Eye Syndromes Endocrine System Diseases Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Glaucoma Glucose Metabolism Disorders Hypertension Keratoconus Lacrimal Apparatus Diseases Macular Degeneration Macular Dystrophy Macular Edema Maculopathy, Age Related Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Ocular Hypertension Retinal Degeneration Retinal Detachment Retinal Diseases Retinal Dystrophies Stroke Trauma Vascular Diseases Vascular Inflammation Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Paris, 75012, France

Location status: Recruiting

Location contact

Michel PAQUES, PU-PH

CONTACT

[email protected]

01 40 02 14 15

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-resolution retinal imaging through adaptive optics

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

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Azedine DJABALI

CONTACT

[email protected]

+33 140021126

Nabil BROUK

CONTACT

[email protected]

+33 140021144

Sponsors and collaborators

Lead sponsor

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Other

Registry information

Official study title

High Resolution and High Speed Multimodal Ophthalmic Imaging

Acronym: IMA-MODE

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Oct 16, 2019
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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