Multimodal Ophthalmic Imaging

Stroke Clinical Trial

— IMA-MODE  

Official title:

High Resolution and High Speed Multimodal Ophthalmic Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04129021
• Other study ID #: P19-03
• Secondary ID: 2019-A00942-55
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2019
• Source: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
• Contact: Tania RILCY
• Phone: +33 140021126
• Email: trilcy[@]15-20.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visualization of a structure of interest and measuring the short-term and long-term reproducibility of the data collected compared to routine systems	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