oCular Examination at Cell RESolution With Optical TransmissionTomography

NCT06976034 | Recruiting

• 1 other identifier: P24-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma Associated With Other Ocular Disorders

Outcome Measures

Primary Outcomes (3)

• Image quality

  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.)

  between 1 day and 4 years

• Endothelial cell density

  Assessment of endothelial cell density.

  between 1 day and 4 years

• Imaging new corneal and lens structures

  corneal and lens structures:measure density in other cell types

  between 1 day and 4 years

Study Arms (2)

Patients with Ocular Disease

EXPERIMENTAL

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

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

Healthy volunteers

ACTIVE COMPARATOR

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

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

Interventions

Optical Transmission Tomography (OTT) DEVICE

Multiple imaging sessions added by research using the systems described (OTT) will be carried out by two different operators at different positions during these sessions.

Healthy volunteers; Patients with Ocular Disease

Optical Coherence Tomography (OCT) DEVICE

Multiple imaging sessions (OCT) already used in standard of care will be performed by two different operators at different positions during these sessions.

Healthy volunteers; Patients with Ocular Disease

Specular Microscopy (SM) DEVICE

Multiple imaging sessions (SM) already used in standard of care will be performed by two different operators at different positions during these sessions.

Healthy volunteers; Patients with Ocular Disease

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Patients:
• 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:
• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts: lead

Study Sites (1)

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Paris, 75012, France

RECRUITING

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Nacim BOUHERAOUA, PU-PH

  Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabil BROUK

CONTACT

00 33 1 40 02 11 44; nbrouk@15-20.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, exploratory, longitudinal, non-randomized, single-center study including patients and healthy volunteers.

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 16, 2025
• Study Start: November 12, 2024
• Primary Completion (Estimated): November 12, 2029
• Study Completion (Estimated): November 12, 2029
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

FR (1)