OCT-guided DSAEK Graft Shaping and Smoothing

NCT01586234 | Terminated DMC

• 1 other identifier: OHSU IRB#00006612 DSAEK
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

Fuchs' Endothelial Dystrophy

Keywords

Fuchs' endothelial dystrophy; DSAEK; Descemet's stripping automated endothelial keratoplasty

Outcome Measures

Primary Outcomes (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.

  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.

  24 months

Study Arms (2)

DSAEK with graft shaping and smoothing

EXPERIMENTAL

Procedure: DSAEK with graft shaping and smoothing

Standard DSAEK

ACTIVE COMPARATOR

Procedure: Standard DSAEK

Interventions

DSAEK with graft shaping and smoothing PROCEDURE

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.

DSAEK with graft shaping and smoothing

Standard DSAEK PROCEDURE

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.

Standard DSAEK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with visual complaint and objective evidence of decreased vision due to corneal edema related to Fuchs' corneal endothelial dystrophy

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Devers Eye Insitute

Portland, Oregon, 97210, United States

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mark Terry, MD

  Devers Eye Institute, Legacy Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mark Terry, MD, Director of Cornea Services

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: April 26, 2012
• Study Start: January 1, 2012
• Primary Completion: August 31, 2014
• Study Completion: August 31, 2014
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

US (1)