Assistive Robotically Aligning Optical Coherence Tomography of the Retinal Periphery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Presence of peripheral retinal break/s - Optical Coherence Tomography (OCT)
研究概览
简要总结
Optical coherence tomography (OCT) is a 3D imaging technology that has seen wide adoption within ophthalmology. However, optical access to the retinal periphery remains a challenge for conventional OCT systems. The study team plans to innovate peripheral retinal OCT imaging technology by first developing the first robotic OCT system capable of autonomously assisting the operator during imaging of the human peripheral retina using 3D active tracking and compensation and then by developing of the first OCT system designed for treatment of the retinal periphery.
详细描述
Purpose and Objectives:
The long-term goal is to develop a system that provides 360° visualization of the peripheral retina replacing the current standard of care for evaluation of the retinal periphery for breaks: indirect ophthalmoscopy with scleral depression, a procedure requiring the examiner to mechanically indent the eye at multiple locations and use an indirect ophthalmoscope and condensing lens to attempt to visualize the retina peripherally and over360°. The rationale for this project is that in addition to being extremely uncomfortable for the patient, this technique requires considerable skill with specialized training.
Furthermore, the exam does not create a direct record of the findings - the examiner must illustrate a guide map from memory for subsequent laser photocoagulation (LP) therapy utilizing this same manual technique. These objectives will be achieved by pursuing two specific aims: 1) Adapt a custom conical mirror contact lens and robotically aligning platform to optically access the peripheral retina with OCT and laser photocoagulation therapy; and 2) Validate peripheral retina robotically aligning OCT against scleral depressed exam in eyes with and without peripheral retinal breaks requiring treatment.
To validate our imaging technique, the investigators will conduct a powered study in eyes with and without known peripheral retina breaks comparing total number of detected peripheral retinal breaks per eye by Peripheral Retina Robotically Aligned OCT (PR-RAOCT) versus clinical exam. As a secondary outcome, the investigators will evaluate subject comfort level following each method. The investigators will recruit patients presenting at the Duke Eye Center with complaints of "flashers and floaters" and have undergone indirect ophthalmoscopy with scleral depression as part of their standard of care.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is able and willing to consent to study participation
- •Subject is more than 18 years of age
- •Healthy adult volunteers without known ocular issues other than refractive error
排除标准
- •Subject is unwilling or unable to provide consent
- •Subject is less than 18 years of age
- •Students or employees under direct supervision of the investigators
- •Subjects with eye trauma, infection of the anterior ocular tissues or corneal conditions like keratoconus, Peter's anomaly, corneal edema, dense cataracts obscuring the retina and dense capsule opacities in pseudophakes
- •The investigators will not exclude subjects based on eyes being phakic, pseudo-phakic, or aphakic.
研究组 & 干预措施
Group 1 - Healthy adult volunteers
Healthy adult volunteers recruited from the patient population, students or employees of Duke University or Duke Eye Center (n=7)
干预措施: Peripheral retina robotically aligned optical coherence tomography (OCT) system (Device)
Group 1 - Healthy adult volunteers
Healthy adult volunteers recruited from the patient population, students or employees of Duke University or Duke Eye Center (n=7)
干预措施: Likert Scales (Other)
Group 2 - Adult participants with "flashers and floaters"
Adult participants recruited from the patient population of Duke Eye Center with complaints of "flashers and floaters" undergoing clinical examination (n=7)
干预措施: Peripheral retina robotically aligned optical coherence tomography (OCT) system (Device)
Group 2 - Adult participants with "flashers and floaters"
Adult participants recruited from the patient population of Duke Eye Center with complaints of "flashers and floaters" undergoing clinical examination (n=7)
干预措施: Likert Scales (Other)
Group 3 - Adult participants with flashers and floaters with no diagnosed peripheral retinal breaks
Adult participants recruited from the patient population of Duke Eye Center with complaints of "flashers and floaters" and a clinical examination showing no breaks in the peripheral retina (n=22)
干预措施: Peripheral retina robotically aligned optical coherence tomography (OCT) system (Device)
Group 3 - Adult participants with flashers and floaters with no diagnosed peripheral retinal breaks
Adult participants recruited from the patient population of Duke Eye Center with complaints of "flashers and floaters" and a clinical examination showing no breaks in the peripheral retina (n=22)
干预措施: Likert Scales (Other)
Group 4 - Adult participants with flashers and floaters with diagnosed peripheral retinal breaks
Adult participants recruited from the patient population of Duke Eye Center with complaints of "flashers and floaters" and a clinical examination showing one or more breaks in the peripheral retinal (n=22)
干预措施: Peripheral retina robotically aligned optical coherence tomography (OCT) system (Device)
Group 4 - Adult participants with flashers and floaters with diagnosed peripheral retinal breaks
Adult participants recruited from the patient population of Duke Eye Center with complaints of "flashers and floaters" and a clinical examination showing one or more breaks in the peripheral retinal (n=22)
干预措施: Likert Scales (Other)
结局指标
主要结局
Presence of peripheral retinal break/s - Optical Coherence Tomography (OCT)
时间窗: Single imaging session (day 1)
Presence of peripheral retinal break as measured by OCT reading
Presence of peripheral retinal break/s - clinical exam
时间窗: Single imaging session (day 1)
Presence of peripheral retinal break as measured by clinical exam
次要结局
- Location of peripheral break(Single imaging session (day 1))
- Comfort evaluation(Single session (day 1))
