NCT03407755Unknown不适用
Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)
Glostrup University Hospital, Copenhagen1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2017年9月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Graft detachment
研究概览
简要总结
This blinded, randomized study compares the use of air and sulfur hexaflouride (SF6) tamponade in Descemet Membrane Endothelial Keratoplasty.
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
- Double (Participant, Investigator)
盲法说明
Surgeon and patient masked to choice of intraocular gas. Study coordinator not masked.
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
- •Eligible for DMEK surgey
排除标准
- •Related to ocular health
- •Re-DMEK or prior penetrating keratoplasty
- •Ocular hypertension resistant to topical medication
- •Previous vitrectomy
- •Minimally invasive glaucoma devices
- •Anterior chamber or iris claw lens
- •Implantable Collamer Lens (ICL)
- •Clinically significant corneal scarring
- •Central corneal thickness >750 µm
- •BCVA < 0.1
- •Related to general health
- •Not able to give informed consent
- •Inability to position correctly due to organic or psychological condition.
- •Related to surgical procedure
- •Graft diameter >9 mm or < 7mm
- •Graft central endothelial cell count < 2000 cells/mm2
- •Graft unfolding duration >1 hour
- •Graft morphology grade 4-5
- •Significant graft decentration (graft contour not visible in microscope)
- •Significant presence of Descemet remnants in the graft-host interface
- •Presence of inward folds
- •Graft 'stroma-surface' placed facing away from recipient stroma
研究组 & 干预措施
Air
Active Comparator
Intraocular 100% atmospheric air (anterior chamber).
干预措施: Intraocular gas (Procedure)
SF6
Experimental
Intraocular 20% sulphur hexaflouride (anterior chamber).
干预措施: Intraocular gas (Procedure)
结局指标
主要结局
Graft detachment
时间窗: Occurence within 3 months postoperative
Significant graft detachment: 1/3 of graft and affecting visual function. Measured by OCT.
次要结局
- Visual acuity(3 months postoperative)
- Gas fill(Serial measurements during postoperative week 1.)
- Complications(Occurence within 3 months postoperative)
- Positioning(72 hours postoperative)
研究者
Mark Alberti
Principal Investigator
Glostrup University Hospital, Copenhagen
研究点 (1)
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