Whole Eye Optical Coherence Tomography (OCT) to Improve Refractive Surgery and Eye Care
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Difference in Radius of Curvature (Rc) of the Posterior Eye From OCT Compared to MRI
研究概览
简要总结
The overall objective is to develop the hardware systems and software algorithms necessary to make accurate measurements of the whole eye with optical coherence tomography (OCT).
The research procedure that each subject will undergo is imaging with the OCT system. Three populations will be included: 1. Normals to ensure the imaging range of the system, 2. Patients with previous LASIK who will be undergoing cataract surgery, and 3. Patients with a history of cataract surgery or high myopia. The third group will also undergo MRI imaging for comparison.
There are no known risks to the subject from imaging with optical coherence tomography beyond what is normal for standard ocular photographic procedures. Light exposure is below ANSI limits. In groups 2 and 3, clinical parameters drawn from the OCT images will be compared to standard of care imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21 years or older.
- •Pseudophakic group: has had prior uncomplicated cataract surgery with a monofocal or toric intraocular lens, able to undergo head MRI
- •High myopia group: refraction equal to or stronger than -6 D spherical equivalent, able to undergo head MRI
排除标准
- •under 21 years of age, unable or unwilling to give consent.
- •Pseudophakic group: complications with cataract surgery or insertion of a multifocal intraocular lens, failure to pass MRI pre-screening (e.g. prior metallic implants, claustrophobic), unable to fixate.
- •High myopia group: failure to pass MRI pre-screening, unable to fixate.
结局指标
主要结局
Difference in Radius of Curvature (Rc) of the Posterior Eye From OCT Compared to MRI
时间窗: 36 months
The radius of curvature of the posterior eye will be measured via surface fitting of the posterior eye data from OCT and MRI. Data reported reflects the Rc of the posterior eye measured by OCT minus the value obtained by MRI measurement.
次要结局
未报告次要终点