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OCT-guided DSAEK Graft Shaping and Smoothing

Oregon Health & Science University (OHSU) logo

Oregon Health & Science University (OHSU)

Status

Terminated

Conditions

Fuchs' Endothelial Dystrophy

Treatments

Procedure: Standard DSAEK
Procedure: DSAEK with graft shaping and smoothing

Study type

Interventional

Funder types

Other

Identifiers

NCT01586234
OHSU IRB#00006612 DSAEK

Details and patient eligibility

About

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).

Full 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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 2 patient groups

DSAEK with graft shaping and smoothing
Experimental group
Treatment:
Procedure: DSAEK with graft shaping and smoothing
Standard DSAEK
Active Comparator group
Treatment:
Procedure: Standard DSAEK

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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