oCular Examination at Cell RESolution With Optical TransmissionTomography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Image quality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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,
研究组 & 干预措施
Patients with Ocular Disease
Patients: an imaging examination by each system (OTT + OCT + specular microscopy) will be carried out by two different operators, and several imaging images will be taken from different positions. These examinations will be performed at the inclusion visit and at follow-up visits as part of the usual management of the disease up to a maximum of 4 years
干预措施: Optical Transmission Tomography (OTT) (Device)
Patients with Ocular Disease
Patients: an imaging examination by each system (OTT + OCT + specular microscopy) will be carried out by two different operators, and several imaging images will be taken from different positions. These examinations will be performed at the inclusion visit and at follow-up visits as part of the usual management of the disease up to a maximum of 4 years
干预措施: Optical Coherence Tomography (OCT) (Device)
Patients with Ocular Disease
Patients: an imaging examination by each system (OTT + OCT + specular microscopy) will be carried out by two different operators, and several imaging images will be taken from different positions. These examinations will be performed at the inclusion visit and at follow-up visits as part of the usual management of the disease up to a maximum of 4 years
干预措施: Specular Microscopy (SM) (Device)
Healthy volunteers
Healthy Volunteers: an imaging examination by each system (OTT + OCT + specular microscopy) will be carried out twice, at the inclusion visit and at 24 months (2 years), the maximum duration of participation for healthy volunteers. Several imaging sessions will be carried out by two different operators at different positions
干预措施: Optical Transmission Tomography (OTT) (Device)
Healthy volunteers
Healthy Volunteers: an imaging examination by each system (OTT + OCT + specular microscopy) will be carried out twice, at the inclusion visit and at 24 months (2 years), the maximum duration of participation for healthy volunteers. Several imaging sessions will be carried out by two different operators at different positions
干预措施: Optical Coherence Tomography (OCT) (Device)
Healthy volunteers
Healthy Volunteers: an imaging examination by each system (OTT + OCT + specular microscopy) will be carried out twice, at the inclusion visit and at 24 months (2 years), the maximum duration of participation for healthy volunteers. Several imaging sessions will be carried out by two different operators at different positions
干预措施: Specular Microscopy (SM) (Device)
结局指标
主要结局
Image quality
时间窗: 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
时间窗: between 1 day and 4 years
Assessment of endothelial cell density.
Imaging new corneal and lens structures
时间窗: between 1 day and 4 years
corneal and lens structures:measure density in other cell types
次要结局
未报告次要终点