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OCT-guided DSAEK Graft Shaping and Smoothing (DSAEK)

Primary Purpose

Fuchs' Endothelial Dystrophy

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DSAEK with graft shaping and smoothing
Standard DSAEK
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fuchs' Endothelial Dystrophy focused on measuring Fuchs' endothelial dystrophy, DSAEK, Descemet's stripping automated endothelial keratoplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Devers Eye Insitute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DSAEK with graft shaping and smoothing

Standard DSAEK

Arm Description

Outcomes

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 3, 2012
Last Updated
April 12, 2018
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT01586234
Brief Title
OCT-guided DSAEK Graft Shaping and Smoothing
Acronym
DSAEK
Official Title
Randomized Clinical Trial of OCT-guided DSAEK Graft Shaping and Smoothing
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 31, 2014 (Actual)
Study Completion Date
August 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs' Endothelial Dystrophy
Keywords
Fuchs' endothelial dystrophy, DSAEK, Descemet's stripping automated endothelial keratoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DSAEK with graft shaping and smoothing
Arm Type
Experimental
Arm Title
Standard DSAEK
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
DSAEK with graft shaping and smoothing
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard DSAEK
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Terry, MD
Organizational Affiliation
Devers Eye Institute, Legacy Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Devers Eye Insitute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States

12. IPD Sharing Statement

Learn more about this trial

OCT-guided DSAEK Graft Shaping and Smoothing

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