Clinical Trial: Comparing Endoglide to Endoserter for DSAEK Graft Insertion

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Prospective Randomized Study Comparing Endothelial Cell Loss Using the Tan EndoGlide With the Endoserter for Insertion of the Donor Graft in Descemets Stripping Endothelial Keratoplasty (DSAEK)

Brief Summary: The purpose of this study is to compare the Tan EndoGlide with the new Endoserter injector in terms of damage to the donor corneal endothelium by comparing the endothelial cell loss at 1 month, 3 months, 6 months, and 1 year post DSAEK (Descemet's Stripping Automated Endothelial Keratoplasty)surgery. There is no data comparing this two injectors.

Detailed Summary:

Descemet's stripping automated endothelial keratoplasty (DSAEK) is a widely performed method of corneal transplantation. It is now considered the standard of care for the treatment of endothelial cell dysfunction. The advantages of this technique include faster visual rehabilitation, decreased risk of allograft rejection, preservation of corneal tectonic strength, stable refraction, reduced irregular astigmatism, and less suture complications.

The standard of care at the Toronto Western Hospital for Dr. Rootman's and Dr. Slomovic's patients with corneal endothelial disease is to perform DSAEK surgery with the Tan Endoglide for insertion of the donor graft. Other surgeons at Toronto Western Hospital use either Busin glide or specifically designed forceps for insertion of the donor graft as part of the standard of care. Still others have advocated the use of the suture pull-through technique.

There is significant disagreement in the literature regarding the DSAEK insertion technique that best preserves the donor endothelium. Some investigators report better results with a forceps or sutures, and others caution against any folding. The less traumatic the insertion to the endothelium, the better the long term survival of the corneal transplant. In addition, surgeons also debate whether large- or small-incision DSAEK is better for the graft's long-term viability, its propensity for postoperative dislocation, and the ease of insertion in the OR. The proposed advantages of the Tan EndoGlide include consistent and reliable delivery of the corneal donor through a small incision with minimal endothelial loss. The advantages of a small-incision DSAEK are, that it provides a more stable wound postoperatively, sutureless surgery, speed, and convenience for combining the procedure with standard phacoemulsification. Balancing the attract
Sponsor: University Health Network, Toronto

Current Primary Outcome: Endothelial cell count after 6 months and 12 months [ Time Frame: 6,12 months post op ]

The patients will be evaluated for endothelial cell loss 6 and 12 post surgery


Original Primary Outcome: Same as current

Current Secondary Outcome: Visual acuity [ Time Frame: 1 month and 3,6,12 months post surgery ]

The patients will be evaluated for Visual acuity stability/improvement at the previous mentioned intervals.


Original Secondary Outcome: Same as current

Information By: University Health Network, Toronto

Dates:
Date Received: February 11, 2013
Date Started: January 2012
Date Completion: January 2014
Last Updated: February 13, 2013
Last Verified: February 2013