oCular Examination at Cell RESolution With Optical TransmissionTomography

Not Applicable

Recruiting

• Conditions: Glaucoma Associated With Other Ocular Disorders

• Registration Number: NCT06976034
• Lead Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Brief Summary

Understanding the pathogenesis of eye diseases has benefited greatly from recent advances in ophthalmic imaging. However, current clinical imaging systems, such as optical coherence tomography (OCT), are limited in terms of resolution, acquisition speed or access to certain eye functions. Our team has participated in the development of a new generation of imaging technology known as optical transmission tomography (OTT), which enables imaging of the anterior parts of the eye with high cellular resolution, a wide field of view and reduced examination delay.

Detailed Description

For healthy subjects: an imaging examination using each system (OTT + OCT + specular microscopy) will be carried out twice, at an interval of two (2) years (inclusion visit + visit at 24 months). Several imaging images will be taken by two different operators during these sessions.

For patients: an imaging examination using each system (OTT + OCT + specular microscopy) will be carried out by two different operators, and several imaging images will be taken. These examinations will be carried out at the inclusion visit and at the following visits according to the disease assessment schedule, lasting up to a maximum of 4 years.

Study Timeline

• Study Start: 2024-11-12
• Status Verified: 2025-05
• Study First Submitted: 2025-05-02
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Primary Completion: 2029-11-12
• Study Completion: 2029-11-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

For Patients:

• 200 subjects aged 18 to 80 years;
• Male or female;
• with an ocular disease affecting the cornea, ocular surface, lens (cataract) or glaucoma, or requiring refractive surgery or post-refractive surgery follow-up;
• Are covered by the French Assurance Maladie;
• Have signed an express, free and informed consent form.

For Healthy volunteers:

• 100 subjects aged 18 to 80 years;
• Male or female;
• Healthy subjects with no known pathology directly or indirectly affecting ocular structures;
• Covered by the French Assurance Maladie.
• Having signed an express, free and informed consent form.

Exclusion Criteria

For all participants:

• Inability to hold a still position on a standard ophthalmic chin rest;
• Conjunctivitis or other contagious contact disease in active phase;
• Having an implanted pacemaker or other electronic medical device;
• Having a predisposition to iridocorneal angle closure;
• Vulnerable persons or persons under legal protection (pregnant or breast-feeding women; persons under guardianship,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Image quality	between 1 day and 4 years	Quality assessed by two blinded experts.; This is an evaluation of image quality in terms of operation according to the following scheme.; Quality assessment: - Sufficient quality : Yes Or No; If no, tick yes, below and fill in the cause: Insufficient quality: ☒ yes ☐ no; Cause: * Technical problem Or; * Patient-related problem (inability to fix, or comply with procedure, etc.)
Endothelial cell density	between 1 day and 4 years	Assessment of endothelial cell density.
Imaging new corneal and lens structures	between 1 day and 4 years	corneal and lens structures:measure density in other cell types

Trial Locations

Locations (1)

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts; 🇫🇷 Paris, France