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Clinical Trials/NCT04620876
NCT04620876RecruitingNot Applicable

Bimodal and Coaxial High Resolution Ophtalmic Imaging

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts2 sites in 1 country1,200 target enrollmentStarted: October 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
1,200
Locations
2
Primary Endpoint
Visualization and image analysis of a structure of interest

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Visualization and image analysis of a structure of interest

Time Frame: From date of inclusion until the date of last documented progression , assessed up to 5 years

The visualization of the structure of interest in at least one area of the image will be considered the main criterion of success.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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