High Resolution, High-speed Multimodal Ophthalmic Imaging

Official title

High Resolution and High Speed Multimodal Ophthalmic Imaging

Overview

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.

Interventions

• 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
• 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 depend

Primary outcome measures

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts — Paris

Publications

• Paques M, Norberg N, Chaumette C, Sennlaub F, Rossi E, Borella Y, Grieve K. Long Term Time-Lapse Imaging of Geographic Atrophy: A Pilot Study. Front Med (Lausanne). 2022 Jun 22;9:868163. doi: 10.3389/fmed.2022.868163. eCollection 2022. PMID 35814763

Identifiers

NCT: NCT04129021 · P19-03 · 2019-A00942-55

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗