A Comparison of Visual Functions and Side-effects After DSAEK or DMEK for Fuchs' Endothelial Dystrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Best corrected visual acuity (BCVA)
研究概览
简要总结
Descemet's stripping automated endothelial keratoplasty (DSAEK) and Descemet's membrane endothelial keratoplasty (DMEK) are becoming increasingly popular as treatments for Fuchs' endothelial dystrophy. However, despite several years of use the incidence of cystoid macular edema and damage related to increased intraocular pressure (IOP), and the forward scattering of light through the eye following DSAEK or DMEK have to our knowledge not been prospectively described. Therefore, this project will be a randomized controlled trial investigating these matters.
详细描述
Purpose:
To investigate 3 different side-effects after DSAEK, DMEK, and cataract extraction (CE) in a randomized controlled trial with 12 months follow-up with CE as an additional control group.
- To investigate the extend of subclinical cystoid macular edema (CME) and epiretinal membrane (ERM) after DSAEK, DMEK, and CE.
- To investigate IOP-related changes after DSAEK, DMEK, and CE in means of pupil diameter and cpRNFLT. Further, to describe iris alterations including Urrets-Zavalia Syndrome (UZS).
- To compare the difference in forward scatter, visual acuity (VA), and low-contrast VA after DSAEK, DMEK, and CE and relate this to the best corrected visual acuity (BCVA). Further, to investigate changes in higher-order aberrations, patient reported outcome measures (PROM), and total corneal refraction after the procedures.
Hypotheses:
- Subclinical CME and ERM are adverse effects that occur equally often following DSAEK, DMEK, and CE.
- Following DSAEK, DMEK, and CE, there are no differences in the amount of IOP-related changes in means of pupil diameter,cpRNFLT thinning or iris alterations.
- Changes in OSI, HOA, PROM, VA, contrast sensitivity, and total corneal refraction occur to the same extend after DSAEK, DMEK, and CE.
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
- Single (Participant)
盲法说明
Subjects randomized to either phaco-DSAEK or phaco-DMEK will be blinded in the study.
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cataract and/or
- •Fuch's endothelial dystrophy
排除标准
- •Diabetes mellitus
- •Retinal vein occlusion
- •Exudative age-related macular degeneration
- •Advanced macular atrophy
- •Ocular trauma
- •Prior corneal grafting
研究组 & 干预措施
Phaco-DSAEK
Subjects randomized to this arm will consist of patients with both Fuchs' endothelial dystrophy and cataract. These will be treated with phacoemulsification and Descemet's stripping automated endothelial keratoplasty.
干预措施: Phaco-DSAEK (Procedure)
Phaco-DMEK
Subjects randomized to this arm will consist of patients with both Fuchs' endothelial dystrophy and cataract. These will be treated with phacoemulsification and Descemet's membrane endothelial keratoplasty.
干预措施: Phaco-DMEK (Procedure)
结局指标
主要结局
Best corrected visual acuity (BCVA)
时间窗: 12 months
BCVA will be measured using the early treatment diabetic retinopathy study (ETDRS) chart.
次要结局
- Forward light scatter(12 months)
- Largest pupil diameter (mm)(12 months)
- Circumpapillary Retinal Nerve Fibre Layer Thickness (cpRNFLT) (µm)(12 months)
- Higher-order aberrations (HOA) (µm)(12 months)
- Cystoid macular edema(3 months)
- Iris contraction velocity (mm/s)(12 months)
- Contrast-sensitivity (Weber contrast units)(12 months)