OCT-guided DSAEK Graft Shaping and Smoothing (DSAEK)
|Fuchs' Endothelial Dystrophy||Procedure: DSAEK with graft shaping and smoothing Procedure: Standard DSAEK|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Clinical Trial of OCT-guided DSAEK Graft Shaping and Smoothing|
- 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. [ Time Frame: 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.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|Experimental: DSAEK with graft shaping and smoothing||
Procedure: DSAEK with graft shaping and smoothing
|Active Comparator: Standard DSAEK||
Procedure: Standard DSAEK
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586234
|United States, Oregon|
|Devers Eye Insitute|
|Portland, Oregon, United States, 97210|
|Principal Investigator:||Mark Terry, MD||Devers Eye Institute, Legacy Health|