Multimodal Ophthalmic Imaging (IMA-MODE)
Primary Purpose
Retinitis Pigmentosa, Maculopathy, Age Related, Macular Dystrophy
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High-resolution retinal imaging through adaptive optics
High-resolution retinal imaging through holographic systems
Sponsored by
About this trial
This is an interventional other trial for Retinitis Pigmentosa
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
Sites / Locations
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High-resolution retinal imaging through adaptive optics
Arm Description
High-resolution retinal imaging through adaptive optics, full field OCT and holographic systems
Outcomes
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04129021
First Posted
August 19, 2019
Last Updated
October 14, 2019
Sponsor
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
1. Study Identification
Unique Protocol Identification Number
NCT04129021
Brief Title
Multimodal Ophthalmic Imaging
Acronym
IMA-MODE
Official Title
High Resolution and High Speed Multimodal Ophthalmic Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-resolution retinal imaging through adaptive optics
Arm Type
Experimental
Arm Description
High-resolution retinal imaging through adaptive optics, full field OCT and holographic systems
Intervention Type
Device
Intervention Name(s)
High-resolution retinal imaging through adaptive optics
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
High-resolution retinal imaging through holographic systems
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visualization of a structure of interest and measuring the short-term and long-term reproducibility of the data collected compared to routine systems
Description
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.
Time Frame
From date of inclusion until the date of last documented progression , assessed up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tania RILCY
Phone
+33 140021126
Email
trilcy@15-20.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Hayet SERHANE
Phone
+33 140021144
Email
hserhane@15-20.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel PAQUES
Organizational Affiliation
Centre Hospitalier National d'Ophtalmologie des Quinze-Vints
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel PAQUES, PU-PH
Phone
01 40 02 14 15
Email
mpaques@15-20.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
35814763
Citation
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.
Results Reference
derived
Learn more about this trial
Multimodal Ophthalmic Imaging
We'll reach out to this number within 24 hrs