Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
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OCT-guided DSAEK Graft Shaping and Smoothing

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
David Huang, Legacy Health System
ClinicalTrials.gov Identifier:
NCT01586234
First received: January 3, 2012
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Fuchs' Endothelial Dystrophy
 Procedure: DSAEK with graft shaping and smoothing
Procedure: Standard DSAEK

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of OCT-guided DSAEK Graft Shaping and Smoothing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

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. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.
Estimated Enrollment: 62
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DSAEK with graft shaping and smoothing 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.
Active Comparator: Standard DSAEK 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.

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586234

Locations
United States, Oregon
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
  More Information

No publications provided

Responsible Party: David Huang, Mark Terry, MD, Director of Cornea Services, Legacy Health System
ClinicalTrials.gov Identifier: NCT01586234     History of Changes
Other Study ID Numbers: OHSU IRB#00006612 DSAEK
Study First Received: January 3, 2012
Last Updated: May 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Fuchs' endothelial dystrophy
DSAEK
Descemet's stripping automated endothelial keratoplasty

Additional relevant MeSH terms:
Fuchs' Endothelial Dystrophy
Corneal Diseases
Corneal Dystrophies, Hereditary
 Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on March 03, 2015