Predictive Factors of Good Results After Primary Descemet's Membrane Endothelial Keratoplasty (DMEK): Retrospective Study About 102 Eyes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 主要终点
- Pre-operative Central Corneal Thickness (CCT),
研究概览
简要总结
Aim: Identify predictive factors of good results after primary Descemet's Membrane Endothelial Keratoplasty (DMEK) in Fuchs Endothelial Corneal Dystrophy (FECD).
82 patients (102 eyes) with Fuchs Endothelial Corneal Dystrophy (FECD) underwent DMEK between March 2016 and March 2018 were analyzed. Follow-up time was 12 months. The studied prognostic criteria were: pre-operative Central Corneal Thickness (CCT), CCT's delta between pre and D15 post-operatively, anterior mean keratometry, pre-operative endothelial cell density (ECD) and postoperative ECD at 6 and 12 months, pre-operative visual acuity, donors' and recipients' ages, recipients' sex, rebubbling and triple procedure (DMEK combined with cataract surgery).
详细描述
Aim: Identify predictive factors of good results after primary Descemet's Membrane Endothelial Keratoplasty (DMEK) in Fuchs Endothelial Corneal Dystrophy (FECD).
A monocentric retrospective observational study was realized at the Regional Hospital Center of Metz-Thionville, Mercy Hospital, Metz, France.
102 eyes of 82 patients with Fuchs Endothelial Corneal Dystrophy (FECD) underwent DMEK between March 2016 and March 2018 were analyzed. Follow-up time was 12 months. The studied prognostic criteria were: pre-operative Central Corneal Thickness (CCT), CCT's delta between pre and D15 post-operatively, anterior mean keratometry, pre-operative endothelial cell density (ECD) and postoperative ECD at 6 and 12 months, pre-operative visual acuity, donors' and recipients' ages, recipients' sex, rebubbling and triple procedure (DMEK combined with cataract surgery). Surgery was considered successful when best spectacle corrected visual acuity (BSCVA) was 0.1 logMar or less (≥0.8) 1 year postoperatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •had advanced FECD associated with visual symptoms and reduced visual acuity .
排除标准
- •Prior intraocular surgery other than cataract
- •Other indications for DMEK surgeries than FECD,
- •Eyes with corneal (except FECD), retinal or optic nerve diseases
- •Per-operative difficulties (tear's graft or complicated unfolding graft)
- •Primary graft failure (cornea that failed to clear in the presence of an attached graft)
- •Secondary graft failure (corneal decompensation after an initial period of a functional graft)
结局指标
主要结局
Pre-operative Central Corneal Thickness (CCT),
时间窗: day 1
Pre-operative CCT (μm) measured by an anterior segment optical coherence tomography (AS-OCT; RS-3000; Nidek Co. Ltd, Japan)
Post-operative Central Corneal Thickness (CCT),
时间窗: Months 12
Post-operative CCT (μm) measured by an anterior segment optical coherence tomography (AS-OCT; RS-3000; Nidek Co. Ltd, Japan)
CCT's delta
时间窗: day 15
CCT's delta (μm) between pre and D15 post-operatively
次要结局
- recipients' sex(day 1)
- anterior mean keratometry(day 1)
- pre-operative endothelial cell density ECD(day1)
- post-operative endothelial cell density (ECD)(12 months)
- pre-operative Visual Acuity(day 1)
- donors' and recipients' ages(day 1)
- rate of rebubbling(months 6)