Bimodal and Coaxial High Resolution Ophtalmic Imaging (AOSLO-OCT)
Primary Purpose
Retinitis Pigmentosa, Maculopathy, Age Related, Macular Dystrophy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bimodal high resolution imaging of the retina
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.
- Participant unable to be followed throughout the study
- Advanced cataract or severe opacities in the anterior segment of the eye.
Sites / Locations
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bimodal and coaxial high resolution imaging of the retina
Arm Description
Optical coherence tomography and Scanning laser ophthalmoscope system using adaptive optics (AO-SLO-OCT)
Outcomes
Primary Outcome Measures
Visualization and image analysis of a structure of interest
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
NCT04620876
First Posted
November 4, 2020
Last Updated
November 4, 2020
Sponsor
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
1. Study Identification
Unique Protocol Identification Number
NCT04620876
Brief Title
Bimodal and Coaxial High Resolution Ophtalmic Imaging
Acronym
AOSLO-OCT
Official Title
Bimodal and Coaxial High Resolution Ophtalmic Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 15, 2024 (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
The knowledge of the pathogenesis of retinal affections, a major cause of blindness, has greatly benefited from recent advances in retinal imaging. However, optical aberrations of the ocular media limit the resolution that can be achieved by current techniques.
The use of an adaptive optics system improves the resolution of ophthalmoscopes by several orders of magnitude, allowing the visualization of many retinal microstructures: photoreceptors, vessels, bundles of nerve fibers.
Recently, the development of the coupling of the two main imaging techniques, the Adaptive Optics Ophthalmoscope with Optical Coherence Tomography, enables unparalleled three-dimensional in vivo cell-scale imaging, while remaining comfortable for the patients.
The purpose of this project is to evaluate the performance of this system for imaging micrometric retinal structures.
Detailed Description
The goal of the project is the capture and analysis of images with AOSLO system, in order to evaluate the performance of this system compared to OCT imaging devices and existing Adaptive Optics used at National Hospital of Ophthalmology.
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
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
Bimodal and coaxial high resolution imaging of the retina
Arm Type
Experimental
Arm Description
Optical coherence tomography and Scanning laser ophthalmoscope system using adaptive optics (AO-SLO-OCT)
Intervention Type
Other
Intervention Name(s)
Bimodal high resolution imaging of the retina
Intervention Description
The protocol consists of performing an Optical coherence tomography and Scanning laser ophthalmoscope system using adaptive optics (AO-SLO-OCT).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 and image analysis of a structure of interest
Description
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.
Participant unable to be followed throughout the study
Advanced cataract or severe opacities in the anterior segment of the eye.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hayet Serhane
Phone
0140021144
Email
hserhane@15-20.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Tania Rilcy
Phone
0140021126
Email
trilcy@15-20.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel PAQUES
Organizational Affiliation
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
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, puph
Phone
01 40 02 14 15
12. IPD Sharing Statement
Learn more about this trial
Bimodal and Coaxial High Resolution Ophtalmic Imaging
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