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NCT Number: NCT06976034

oCular Examination at Cell RESolution With Optical TransmissionTomography

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Paris, 75012, France

Location status: Recruiting

Location contact

Nabil BROUK

CONTACT

[email protected]

00 33 1 40 02 11 44

Nacim BOUHERAOUA

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Image quality

    Time frame: 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.)
  2. Endothelial cell density

    Time frame: between 1 day and 4 years

    Assessment of endothelial cell density.

  3. Imaging new corneal and lens structures

    Time frame: between 1 day and 4 years

    corneal and lens structures:measure density in other cell types

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Other

Registry information

Acronym: CERES-OTT

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
May 16, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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