Clinical trial NCT04620876: Bimodal and Coaxial High Resolution Ophtalmic Imaging
Official title: Bimodal and Coaxial High Resolution Ophtalmic Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinitis Pigmentosa
Maculopathy, Age Related
Macular Dystrophy
Macular Edema
Retinal Detachment
Retinal Degeneration
Glaucoma
Vascular Inflammation
Hypertension
Stroke
Diabetes
Lead sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Visualization and image analysis of a structure of interest
timeFrame: From date of inclusion until the date of last documented progression , assessed up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Study officials:
affiliation: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
name: Michel PAQUES
role: PRINCIPAL_INVESTIGATOR
References: