High Resolution, High-speed Multimodal Ophthalmic Imaging
IMA-MODE
High Resolution and High Speed Multimodal Ophthalmic Imaging
2 other identifiers
interventional
1,200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 3, 2019
CompletedFirst Submitted
Initial submission to the registry
August 19, 2019
CompletedFirst Posted
Study publicly available on registry
October 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
November 18, 2025
November 1, 2025
8 years
August 19, 2019
November 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
High-resolution retinal imaging through adaptive optics
EXPERIMENTALHigh-resolution retinal imaging through adaptive optics, full field OCT and holographic systems
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- People over 18
- Patient with a pathology affecting the eye or healthy volunteer
- Participant who signed the consent
- Beneficiaries of the health insurance
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, 75012, France
Related Publications (1)
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: 35814763DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel PAQUES
Centre Hospitalier National d'Ophtalmologie des Quinze-Vints
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2019
First Posted
October 16, 2019
Study Start
July 3, 2019
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
November 18, 2025
Record last verified: 2025-11