OCT-guided DSAEK Graft Shaping and Smoothing

Sponsor

Oregon Health and Science University (Other)

Overall Status

Terminated

CT.gov ID

NCT01586234

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Fuchs' Endothelial Dystrophy	Procedure: DSAEK with graft shaping and smoothing Procedure: Standard DSAEK	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Aug 31, 2014

Actual Study Completion Date :

Aug 31, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DSAEK with graft shaping and smoothing	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.
Active Comparator: Standard DSAEK	Procedure: 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.

Arm

Intervention/Treatment

Experimental: DSAEK with graft shaping and smoothing

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.

Active Comparator: Standard DSAEK

Procedure: 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.

Outcome Measures

Primary Outcome Measures

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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Devers Eye Insitute	Portland	Oregon	United States	97210

Sponsors and Collaborators

Oregon Health and Science University

Investigators

Principal Investigator: Mark Terry, MD, Devers Eye Institute, Legacy Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Huang, Mark Terry, MD, Director of Cornea Services, Legacy Health System

ClinicalTrials.gov Identifier:

NCT01586234

Other Study ID Numbers:

OHSU IRB#00006612 DSAEK

First Posted:

Apr 26, 2012

Last Update Posted:

Apr 17, 2018

Last Verified:

Apr 1, 2018

Keywords provided by David Huang, Mark Terry, MD, Director of Cornea Services, Legacy Health System

Fuchs' endothelial dystrophy

DSAEK

Descemet's stripping automated endothelial keratoplasty

Additional relevant MeSH terms:

Fuchs' Endothelial Dystrophy

Study Results

No Results Posted as of Apr 17, 2018