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Clinical Trials in France / NCT06976034
Recruiting Not applicable

oCular Examination at Cell RESolution With Optical TransmissionTomography

NCT06976034 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Phase
Not applicable
Started
2024-11-12
Last updated
2025-05-16

Condition(s) studied

Glaucoma Associated With Other Ocular Disorders

Investigational drug(s) / intervention(s)

Optical Transmission Tomography (OTT)Optical Coherence Tomography (OCT)Specular Microscopy (SM)

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

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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 outcome measure(s)

  • Image quality — 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.)
  • Endothelial cell density — between 1 day and 4 years
    Assessment of endothelial cell density.
  • Imaging new corneal and lens structures — between 1 day and 4 years
    corneal and lens structures:measure density in other cell types

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts Paris France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06976034 on ClinicalTrials.gov ↗ ← All trials in France