Health TrialsbyHealthPanel

oCular Examination at Cell RESolution With Optical TransmissionTomography

ConditionGlaucoma Associated With Other Ocular Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCentre Hospitalier National d'Ophtalmologie des Quinze-Vingts

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Patients with Ocular DiseaseExperimental treatment 3 interventions
Group B: Healthy volunteersActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.)

Time frame
between 1 day and 4 years
2

Endothelial cell density

Assessment of endothelial cell density.

Time frame
between 1 day and 4 years
3

Imaging new corneal and lens structures

corneal and lens structures:measure density in other cell types

Time frame
between 1 day and 4 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Lead sponsor

Source ClinicalTrials.gov
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