oCular Examination at Cell RESolution With Optical TransmissionTomography

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Image quality [Срок оценки: between 1 day and 4 years]
• Endothelial cell density [Срок оценки: between 1 day and 4 years]
• Imaging new corneal and lens structures [Срок оценки: between 1 day and 4 years]

Критерии участия

Критерии включения

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.

Критерии исключения

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,

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts — Paris

Идентификаторы

NCT: NCT06976034 · P24-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗