NCT04129021

High Resolution, High-speed Multimodal Ophthalmic Imaging

High Resolution and High Speed Multimodal Ophthalmic Imaging

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-07-03
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2019-10-16
• Last updated: 2025-11-18

Locations

1 site across 1 country: France