Determination of Feasibility of Intraoperative Spectral Domain Microscope Combined/Integrated OCT Visualization During En Face Retinal and Ophthalmic Surgery: DISCOVER Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,911
- 试验地点
- 1
- 主要终点
- To assess feasibility of microscope-integrated intraoperative OCT
研究概览
简要总结
Optical coherence tomography (OCT )provides high resolution information regarding the anatomic structure of the tissues of the eye in a cross-sectional and 3 dimensional view. Much of this information is not able to be visualized by a clinician. Utilizing this information during surgery will allow for the ophthalmic surgeons to better understand how surgical procedures impact the anatomic structure of the eye.
In this study an OCT device that has been built into the microscope (rather than mounted on the side or held in the surgeon's hand) and will be utilized to take images at various milestones during surgery to assess feasibility and potential utility of this technology. Since it is built into the microscope, there are potential significant advantages over a separate system including increased efficiency, improved working distance, and the ability to visualize tissue-instrument interactions.
详细描述
Optical coherence tomography (OCT) has become a critical component to the evaluation of ophthalmic disease. Similar to the ultrasound, OCT uses light to reconstruct an image of the tissue of interest. In effect, OCT functions almost like a light biopsy, allowing clinicians to visualize subtle changes in the tissue, such as macular edema or subretinal fluid. OCT in the clinic setting has become the gold standard for monitoring diseases such as macular degeneration and diabetic retinopathy;and it has become one of the most frequently ordered diagnostic test in ophthalmology.
Due to the restraints in the size and structure of the imaging equipment, the use of OCT in the operating room has been limited. More recently, modifications to OCT table-tops models as well as the development of hand-held OCT probes have allowed for the translation of OCT technology into the operating room. The high resolution anatomic information that is gained from the OCT imaging is a natural complement to the ophthalmic surgeon. Using OCT during vitreoretinal surgery has revealed subtle changes in the microarchitecture of the retinal diseases such as retinal detachment, macular hole and optic pit, that were not previously known. Our research team has been examining intraoperative OCT in the operating room using both a handheld and microscope-mounted portable spectral domain OCT probe with excellent success and an outstanding safety record.
In this study an OCT device that has been built into the microscope (rather than mounted on the side or held in the surgeon's hand) and will be utilized to take images at various milestones during surgery to assess feasibility and potential utility of this technology. Since it is built into the microscope, there are potential significant advantages over a separate system including increased efficiency, improved working distance, and the ability to visualize tissue-instrument interactions.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •The study population includes any patient requiring ophthalmic surgery
排除标准
- •Under the age of 18 years.
- •Cognitive/Mentally impaired or unable to provide consent
结局指标
主要结局
To assess feasibility of microscope-integrated intraoperative OCT
时间窗: 3 years
Feasibility will be assessed as the percentage of cases where OCT images were successfully obtained with a microscope-integrated system
次要结局
- To assess utility of microscope-integrated intraoperative OCT on surgical decision-making(3 years)
研究者
Justis Ehlers
Assistant Professor of Ophthalmology
The Cleveland Clinic