oCular Examination at Cell RESolution With Optical TransmissionTomography

Last updated: May 15, 2025
Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glaucoma

Treatment

Optical Transmission Tomography (OTT)

Specular Microscopy (SM)

Optical Coherence Tomography (OCT)

Clinical Study ID

NCT06976034
P24-01
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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) orglaucoma, 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 ocularstructures;

  • Covered by the French Assurance Maladie.

  • Having signed an express, free and informed consent form.

Exclusion

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-feedingwomen; persons under guardianship,

Study Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Optical Transmission Tomography (OTT)
Phase:
Study Start date:
November 12, 2024
Estimated Completion Date:
November 12, 2029

Study 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.

Connect with a study center

  • Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

    Paris, 75012
    France

    Active - Recruiting

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