Clinical trial NCT06976034: oCular Examination at Cell RESolution With Optical TransmissionTomography
Official title: oCular Examination at Cell RESolution With Optical TransmissionTomography
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma Associated With Other Ocular Disorders
Lead sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, exploratory, longitudinal, non-randomized, single-center study including patients and healthy volunteers.
Primary purpose: OTHER

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.

Eligibility criteria: 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,

Primary outcomes:
measure: Image quality
timeFrame: between 1 day and 4 years
measure: Endothelial cell density
timeFrame: between 1 day and 4 years
measure: Imaging new corneal and lens structures
timeFrame: between 1 day and 4 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: Nacim BOUHERAOUA, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: