OCT-guided DSAEK Graft Shaping and Smoothing

Fuchs' Endothelial Dystrophy Clinical Trial

— DSAEK  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01586234
• Other study ID #: OHSU IRB#00006612 DSAEK
• Status: Terminated
• Phase: N/A
• First received: January 3, 2012
• Last updated: April 12, 2018
• Start date: January 2012
• Est. completion date: August 31, 2014

Study information

• Verified date: April 2018
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: August 31, 2014
• Est. primary completion date: August 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults with visual complaint and objective evidence of decreased vision due to corneal edema related to Fuchs' corneal endothelial dystrophy

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fuchs' Endothelial Dystrophy

Intervention

Procedure:
• DSAEK with graft shaping and smoothing
A 5mm incision will be made in the sclera (white portion) of the eye, approximately 1mm from the edge of the cornea The tissue on the underside of the cornea (endothelium) will be scraped away 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.
• Standard DSAEK
A 5mm incision will be made in the sclera (white portion) of the eye, approximately 1mm from the edge of the cornea The tissue on the underside of the cornea (endothelium) will be scraped away The graft from the donor cornea will be inserted through the incision and placed against the endothelium of the host cornea.

Locations

Country	Name	City	State
United States	Devers Eye Insitute	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	24 months