IRB Number:

06-004594

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This study is being done to compare the outcomes of different corneal transplantation techniques. Specifically, we wish to compare which technique results in better vision, faster visual recovery, and longer transplanted cell survival. The surgical techniques to be compared are DLEK (deep lamellar endothelial keratoplasty), DSEK (Descemet stripping with endothelial keratoplasty), and PK (penetrating keratoplasty).

Who is Eligible to Participate in the Study?

Males and females, ages 18 to 80, with corneal endothelial decompensation may be eligible to participate in this study.

Minimum Age:

18

Maximum Age:

80

What is Involved With this Study?

Participants will undergo a series of tests to be performed on the operated eye before the surgical procedure and again at 1, 3, 6, 12, 24, 36 and 60 months after the operation. For both the DLEK and DSEK operations, the cornea, the front clear window to the eye, is replaced with a healthy human cornea from someone who has died and donated organs. For DLEK and DSEK, only the inside portion of the cornea button is removed from the patient?s eye and replaced with a partial thickness button of donor cornea. For the PK operation, a small full-thickness button-shaped piece of cornea is removed from the eye and replaced with a similarly shaped piece from the donor cornea.

How long will the Study run?

Participants will be in the study for up to 5 years.

Who can I Contact for Additional Information on this Trial?

For more information or to participate in this study, please contact Becky Nielsen at 507-284-5833.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 11/05/2008