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OCT-guided DSAEK Graft Shaping and Smoothing

NCT01586234 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-04-17

No results posted yet for this study

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).

Conditions

  • Fuchs' Endothelial Dystrophy

Interventions

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.

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.

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Mark Terry, MD · Devers Eye Institute, Legacy Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01586234 on ClinicalTrials.gov