NCT01586234

OCT-guided DSAEK Graft Shaping and Smoothing

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Fuchs' Endothelial Dystrophy

Interventions

Type	Name	Description
PROCEDURE	DSAEK with graft shaping and smoothing	1. A 5mm incision will be made in the sclera (white portion) of the eye, approximately 1mm from the edge of the cornea 2. The tissue on the underside of the cornea (endothelium) will be scraped away 3. The graft from the donor cornea (previously smoothed with a laser) will be inserted through the incision and placed against the endothelium of the host cornea.
PROCEDURE	Standard DSAEK	1. A 5mm incision will be made in the sclera (white portion) of the eye, approximately 1mm from the edge of the cornea 2. The tissue on the underside of the cornea (endothelium) will be scraped away 3. The graft from the donor cornea will be inserted through the incision and placed against the endothelium of the host cornea.

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-08-31
• Completion: 2014-08-31
• First posted: 2012-04-26
• Last updated: 2018-04-17

Locations

1 site across 1 country: United States