oCular Examination at Cell RESolution With Optical TransmissionTomography (CERES-OTT)

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Status: Enrolling

Conditions: Glaucoma Associated With Other Ocular Disorders

Treatments: Device: Optical Transmission Tomography (OTT); Device: Optical Coherence Tomography (OCT); Device: Specular Microscopy (SM)

Study type: Interventional

Funder types: Other

Identifiers

NCT06976034

P24-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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,

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Patients with Ocular Disease

Experimental group

Description:

Patients: an imaging examination by each system (OTT + OCT + specular microscopy) will be carried out by two different operators, and several imaging images will be taken from different positions. These examinations will be performed at the inclusion visit and at follow-up visits as part of the usual management of the disease up to a maximum of 4 years

Treatment:

Device: Specular Microscopy (SM)

Device: Optical Coherence Tomography (OCT)

Device: Optical Transmission Tomography (OTT)

Healthy volunteers

Active Comparator group

Description:

Healthy Volunteers: an imaging examination by each system (OTT + OCT + specular microscopy) will be carried out twice, at the inclusion visit and at 24 months (2 years), the maximum duration of participation for healthy volunteers. Several imaging sessions will be carried out by two different operators at different positions

Treatment:

Device: Specular Microscopy (SM)

Device: Optical Coherence Tomography (OCT)

Device: Optical Transmission Tomography (OTT)