Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Graft attachment
研究概览
简要总结
This randomized controlled trial evaluates the efficacy and safety of postoperative supine head positioning on graft attachment after Descemet membrane endothelial keratoplasty in patients with Fuchs' endothelial corneal dystrophy (FECD).
详细描述
In Descemet membrane endothelial keratoplasty (DMEK), an air or gas bubble is inserted in the anterior chamber of the eye to keep the ultrathin endothelial corneal graft attached to the patients own cornea. Supine positioning is thought to improve attachment by using the tamponade effect of the bubble. At present, it is unclear how long supine positioning is required. Positioning regimens vary between one hour to over one week. In this trial, the investigators will assess if prolonged supine positioning for 5 days improves graft attachment and long-term outcomes compared to supine positioning for 1 day.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care providers, surgeons, and investigators will be masked until the first postoperative day after DMEK. Investigators will open the opaque envelope with the study assignment together with the participant and inform care providers on the positioning regimen for the next 4 days.
The primary outcome will be assessed by a masked investigator using a trained and validated neural network for image segmentation.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of advanced Fuchs' endothelial corneal dystrophy (FECD)
- •Indication for corneal endothelial transplantation (Descemet Membrane Endothelial Keratoplasty - DMEK)
排除标准
- •Other corneal diseases (i.e. corneal scars, corneal dystrophies except FECD, corneal inflammation / infection)
- •Regular use of drugs potentially affecting the cornea (i.e. amiodarone, chloroquine, triptan, isotretinoin, use of contact lenses in past four weeks, anesthetic eye drops)
- •Diabetes mellitus with endorgan complications)
- •Lack of fixation during corneal tomography
- •Bedridden
结局指标
主要结局
Graft attachment
时间窗: At two weeks after DMEK
Area of graft detachment, quantified from a trained and validated neural network for image segmentation of anterior segment optical coherence tomography
次要结局
- Safety of supine positioning(At two weeks and 3 months after DMEK)
- Disability glare(At 3, 12, and 24 months after DMEK)
- Subjective visual function(At 3, 12, and 24 months after DMEK)
- Visual acuity(At 3, 12, and 24 months after DMEK)
- Graft health: endothelial cell density(At 3, 12, and 24 months after DMEK)
- Rebubbling(At two weeks and 3 months after DMEK)
- Graft health(At 12, and 24 months after DMEK)
- Patient-reported visual disability(At 3, 12, and 24 months after DMEK)
- Corneal backscatter(At 3, 12, and 24 months after DMEK)
- Corneal edema(At 2 weeks and at 3, 12, and 24 months after DMEK)