Clinical Trial: OCT-guided DSAEK Graft Shaping and Smoothing

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: Randomized Clinical Trial of OCT-guided DSAEK Graft Shaping and Smoothing

Brief Summary: 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).

Detailed Summary:

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.


Sponsor: Oregon Health and Science University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Oregon Health and Science University

Dates:
Date Received: January 3, 2012
Date Started: January 2012
Date Completion: December 2015
Last Updated: May 16, 2013
Last Verified: May 2013