OCT-guided DSAEK Graft Shaping and Smoothing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-08-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Fuchs' Endothelial Dystrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DSAEK with graft shaping and smoothing

Group Type EXPERIMENTAL

DSAEK with graft shaping and smoothing

Intervention Type 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.

Standard DSAEK

Group Type ACTIVE_COMPARATOR

Standard DSAEK

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No