Corneal Transplantation Guided by OCT RESCAN: Pre-op, Intra-op and Post-op Evaluation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Assess optimal maneuvers in corneal transplantation (separation layers)
研究概览
简要总结
The investigators will evaluate 30 patients with surgical indication for corneal transplantation. Participants will be divided according to the following diseases diseases: keratoconus, bullous keratopathy, corneal dystrophies. Participants will be informed about the risks and benefits of the study and sign an informed consent form. In the preoperative evaluation will be submitted to a complete ophthalmologic examination with complementary tests, such as optical coherence tomography.
One group of participants will undergo corneal surgery using the OCT Lumera microscope RESCAN - ZEISS and another group with a conventional microscope. Everyone will have their filmed and documented surgery. The team of surgeons will answer the questionnaire on the surgical difficulty about the ease of assessing corneal transplantation. After surgery, participants will be assessed on days 1, 7,15, 30, 60, 90 and 180 after surgery.
Surgeries and study procedures will be performed by the same team of surgeons and performed by IPEPO - Paulista Institute of Studies and Research in Ophthalmology / Vision Institute.
详细描述
Participants will be allocated in one of the following groups:
- Control Group The control group will undergo corneal transplant with conventional microscope without coupled OCT. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation (ANNEX 1).
- Group OCT RESCAN In the group microscope coupled to OCT, patients will undergo retinal surgery using the Lumera Microscope WITH RESCAN OCT - ZEISS. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation (ANNEX 1).
The investigators will evaluate intraoperative conditions, complications, operative time and postoperative results in both groups.
All patients will be monitored and evaluated with full ophthalmological examination in all postoperative visits (day 1, 7,15,30, 60, 90, 180) and will be subjected to the following tests:
- Measurement of visual acuity with best correction
- Previous Biomicroscopy
- Corneal Topography
- tonometry
- Optical coherence tomography (OCT)
- Microscopy speculate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Visual acuity less than 20/60 in the affected eye
- •18 years at least
- •Diagnostic of the following diseases:
- •keratoconus
- •Keratopathy Bullosa
- •Corneal dystrophy
排除标准
- •Better visual acuity than or equal to 20/60
结局指标
主要结局
Assess optimal maneuvers in corneal transplantation (separation layers)
时间窗: Day 0
assessed by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)
次要结局
- Compare the time of surgery between groups(Day 0)
- To describe the surgical difficulty for corneal transplantation(Day 0)
- Change of Day 1 Ocular inflammation at 1 month (Day 30)(from Day1 to Day30)
- Change from Baseline Intraocular Pressure at 6 months (Day180)(from Baseline to Day 180)
- Change from Baseline Visual Acuity at 6 months (Day 180)(from Baseline to Day 180)
研究者
Walton Nose
Professor of Ophthalmology
Federal University of São Paulo