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

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Status: Enrolling

Conditions: Keratoconus; Retinal Detachment; Stroke; Dry Eye; Trauma; Macular Dystrophy; Macular Edema; Corneal Dystrophy; Vascular Inflammation; Hypertension; Diabetes; Retinal Degeneration; Glaucoma; Retinitis Pigmentosa; Maculopathy, Age Related

Treatments: Device: High-resolution retinal imaging through adaptive optics; Device: High-resolution retinal imaging through holographic systems

Study type: Interventional

Funder types: Other

Identifiers

NCT04129021

P19-03

2019-A00942-55 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,200 participants in 1 patient group

High-resolution retinal imaging through adaptive optics

Experimental group

Description:

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

Treatment:

Device: High-resolution retinal imaging through holographic systems

Device: High-resolution retinal imaging through adaptive optics