Efficiency of Intraoperative Optical Coherence Tomography (iOCT) in Eye Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Attachment of the transplanted DMEK lamella.
研究概览
简要总结
Efficiency of Intraoperative Optical Coherence Tomography (iOCT)
Hypothesis:
The use of iOCT during surgery offers the advantage of a new view of the operating field, theoretically allows more precise performance and can also change decision-making mechanisms during surgery with more precise visual control of some surgical steps (incision adaptation, differentiation of healthy and pathological tissue, placement of the implant, graft, etc.) The disadvantage is the prolongation of the operation and thus the theoretical increase in possible complications related to the operation (bleeding, infection, patient subjective problems - pain, restlessness, poorer cooperation and the resulting other possible risks, such as unexpected patient movement).
Aim:
Determining the effectiveness of iOCT use in different types of eye surgery. Evaluation of advantages and disadvantages of using iOCT.
详细描述
Methods:
The effectiveness of iOCT use will be monitored in three types of microsurgical eye surgery:
- Lamellar corneal transplantation type DMEK
- Antiglaucoma surgery - Deep sclerectomy with implantation of subchoroidal implant Esnoper Clip
- Pars plana vitrectomy with epiretinal membrane peeling
For each type of the surgery, the investigators expect to perform about 50 surgeries, individual procedures will be randomly divided into 2 subgroups of 25 patients with and without the use of iOCT during the operation.
Perioperatively, the surgeon will record the number of complications, the net time of the operation and impressions using a questionnaire. The patient will evaluate the subjective perception of the operation using a questionnaire (pain, pressure, subjectively perceived duration of the operation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 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
- 否
入选标准
- •Clinical diagnosis of Bullous keratopathy and Fuchs dystrophy of the cornea indicated for surgical treatment DMEK
- •Clinical diagnosis of Primary open angle glaucoma and Normotension glaucoma indicated for surgical treatment Deep sclerectomy with implantation of subchoroidal implant Esnoper Clip
- •Clinical diagnosis of Epiretinal membrane indicated for surgical treatment Pars plana vitrectomy with epiretinal membrane peeling
排除标准
- •If it is not possible to take an iOCT image
- •Uveitis in anamnestic history
- •Other ocular diagnosis deteriorating visual acuity (eg. age related macular degeneration, diabetic macular edema, macular scars)
结局指标
主要结局
Attachment of the transplanted DMEK lamella.
时间窗: 6 months postoperatively
The investigators will evaluate the attachment of the transplanted DMEK lamella (respectively % area of lamella ablation) on the slit lamp.
Density of the transplanted endothelium cells.
时间窗: 6 months postoperatively
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
Correct localization of the Esnoper Clip implant and confirmation of its functionality.
时间窗: 6 months postoperatively
The investigators will evaluate correct localization of the Esnoper Clip implant and confirmation of its functionality (decentration of the implant in millimeters, functionality expressed by the size of filtration into the subcleral and suprachoroidal space) using stationary OCT.
Frequency of epiretinal membrane residues.
时间窗: At the first week postoperatively.
The investigators will evaluate the frequency of epiretinal membrane residues using stationary OCT.
Histological verification of tissues identified on the basis of iOCT during surgery.
时间窗: At the first week postoperatively.
The investigators in cooperation with pathologist will histologicaly verificate tissues identified on the basis of iOCT during surgery in Deep sclerectomy and Pars plana vitrectomy patients.
次要结局
- Inflammation reaction(6 months postoperatively)
- Visual acuity(6 months postoperatively)
- Intraocular pressure(6 months postoperatively)
研究者
Tomas Benda, MD, FEBO
Principal Investigator
Somich, s.r.o.