Study of Human Ocular Hemodynamics by Holography Dopple
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 148
- 主要终点
- Feasibility of blood flow monitoring
研究概览
简要总结
Prospective, interventional, non-randomized, open-label study, multi-center, Gehan-designed study with sequential inclusions in each subgroup, ranging from 4 subjects to a maximum 37 subjects per subgroup included
详细描述
Retinal perfusion can be affected by a number of local or general pathologies; however, there is currently no commercially available device to provide accurate measurements of retinal blood flow. The company Quantel Medical is developing a medical imaging device HoloDoppler (hereinafter referred to as the "HoloDoppler system"). system. In order to better define its medical utility, we aim to evaluate its reproducibility and accuracy in healthy subjects and those with conditions that may affect ocular blood flow.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Criteria common to both populations ( patients and healthy volunteers) :
- •Age ≥ 18 years and < 75 years;
- •Having received informed information about the study and having signed a consent to participate in the study;
- •Affiliated or covered by social security
- •Criteria for healthy volunteers :
- •No ocular or systemic disease deemed to affect ocular circulation by an investigator
- •Specific criteria for patients:
- •Subjects usually followed at one of the recruiting centers;
- •Patients with chronic glaucoma, for whom a therapeutic modification is planned in the short term;
- •Patients with carotid stenosis;
- •Patients with choroidal pathology: pachychoroidism having led to pigment epithelium anomalies.
排除标准
- •For all participants:
- •Persons covered by articles L1121-5 to L1121-8 of the CSP (all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial decision or administrative decision, minors, and persons under legal protection: guardianship or curatorship);
- •Women of childbearing age not using an effective method of contraception, or positive pregnancy test (blood or urine);
- •Participants allergic to tropicamide when using pupillary dilatation;
- •Inability of the subject to maintain a stable sitting position for research procedures;
- •Temporary contraindication to HoloDoppler:
- •Patient suffering from viral conjunctivitis or any other infectious disease;
- •Patient with skin lesions on the neck or forehead, for which contact with a chin strap is not recommended.
- •Impossibility of making acquisitions of interest (e.g. due to a pupil diameter that is too small, advanced cataracts, nystagmus, etc.).
- •Wearing glasses or contact lenses to correct a refractive disorder is not considered a criterion for non-inclusion.
结局指标
主要结局
Feasibility of blood flow monitoring
时间窗: 15 minutes
Evaluate the feasibility of retinal blood flow measurement with HoloDoppler imaging
Assessment of the reproducibility of blood flow measurements
时间窗: 15 minutes
Determine the reproducibility of retinal blood flow measurements with holodoppler at 15 minutes with the same operator and two different operators 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.).
statistical precision measurements by intra-class coefficient (ICC)
时间窗: 15 minutes
evaluate the accuracy of measurements or assessments by different operators the HoloDoppler system
次要结局
未报告次要终点