Randomized Clinical Trial of OCT-guided DSAEK Graft Shaping and Smoothing
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Number of patients with better post-operative spectacle-corrected visual acuity when implant graft is smoothed with eximer laser versus no smoothing of the graft.
研究概览
简要总结
The primary goal of this study is to determine if excimer laser smoothing of the cornea before Descemet's stripping automated endothelial keratoplasty (DSAEK)improves postoperative Best Spectacle Corrected Visual Acuity (BSCVA).
详细描述
Many surgeons are moving away from full thickness corneal transplantation (because of risks involving rejection, irregular astigmatism, and wound dehiscence) to partial thickness transplantations of either the anterior or posterior (endothelial) layers. However this technique is not without its drawbacks. DSAEK uses a mechanical microkeratome to cut the graft, but vision is limited by the roughness of the cut surface.
DSAEK can lead to significant refractive error due to the non-uniform shape of the microkeratome cut graft, and the roughness of the microkeratome cut surface limits vision to an average of 20/31. Optical coherence tomography (OCT)-guided laser shaping and smoothing may improve the refractive and visual outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Adults with visual complaint and objective evidence of decreased vision due to corneal edema related to Fuchs' corneal endothelial dystrophy
排除标准
- •Inability to give informed consent
- •Inability to maintain stable fixation for OCT imaging
- •Inability to commit to required visits to complete the study
- •Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery
研究组 & 干预措施
DSAEK with graft shaping and smoothing
干预措施: DSAEK with graft shaping and smoothing (Procedure)
Standard DSAEK
干预措施: Standard DSAEK (Procedure)
结局指标
主要结局
Number of patients with better post-operative spectacle-corrected visual acuity when implant graft is smoothed with eximer laser versus no smoothing of the graft.
时间窗: 24 months
To determine whether OCT-guided excimer laser graft shaping improves postoperative visual acuity, including reduction of postoperative hyperopic shift and improvement of the predictability of postoperative refraction.
次要结局
未报告次要终点
研究者
David Huang
Mark Terry, MD, Director of Cornea Services
Legacy Health System