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OCT-guided DSAEK Graft Shaping and Smoothing (DSAEK)

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ClinicalTrials.gov Identifier: NCT01586234
Recruitment Status : Terminated
First Posted : April 26, 2012
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
David Huang, Legacy Health System

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : January 2012
Actual Primary Completion Date : August 31, 2014
Actual Study Completion Date : August 31, 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 26, 2012    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Keywords provided by David Huang, Legacy Health System:
Fuchs' endothelial dystrophy
DSAEK
Descemet's stripping automated endothelial keratoplasty

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