OCT-guided DSAEK Graft Shaping and Smoothing (DSAEK)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01586234|
Recruitment Status : Terminated
First Posted : April 26, 2012
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fuchs' Endothelial Dystrophy||Procedure: DSAEK with graft shaping and smoothing Procedure: Standard DSAEK||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Clinical Trial of OCT-guided DSAEK Graft Shaping and Smoothing|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||August 31, 2014|
|Actual Study Completion Date :||August 31, 2014|
|Experimental: DSAEK with graft shaping and smoothing||
Procedure: DSAEK with graft shaping and smoothing
|Active Comparator: Standard DSAEK||
Procedure: Standard DSAEK
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586234
|United States, Oregon|
|Devers Eye Insitute|
|Portland, Oregon, United States, 97210|
|Principal Investigator:||Mark Terry, MD||Devers Eye Institute, Legacy Health|