High Resolution, High-speed Multimodal Ophthalmic Imaging

Not Applicable

Recruiting

• Conditions: Macular Dystrophy; Retinal Degeneration; Retinitis Pigmentosa; Hypertension; Stroke; Corneal Dystrophy; Macular Edema; Vascular Inflammation; Keratoconus; Dry Eye

• Registration Number: NCT04129021
• Lead Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

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.

Study Timeline

• Study Start: 2019-07-03
• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts; 🇫🇷 Paris, France