Comparing Endoglide to Endoserter for DSAEK Graft Insertion

Fuch's Endothelial Dystrophy Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01791075
• Other study ID #: REB 10-0631-B
• Status: Recruiting
• Phase: N/A
• First received: February 11, 2013
• Last updated: February 13, 2013
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: February 2013
• Source: University Health Network, Toronto
• Contact: Uri Elbaz, MD
• Phone: 4163175662
• Email: urielbaz[@]gmail.com
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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 attractiveness of small-incision DSAEK with the concern for endothelial injury from donor folding and forceps compression, the Endosaver (Ocular Systems, Inc., Winston-Salem, NC) a novel DSAEK injector device, has been recently introduced. It allows the surgeon to insert unfolded tissue without a forceps through a 4-mm clear corneal incision.

Both devices have been approved for use by Health Canada as a Class 1 device (http://www.angioedupro.com/Sharpoint/index.php?seek=394).

Recently, the results of a randomised prospective study being conducted by Dr. D. Tan (inventor of the Tan EndoGlide) were published. In this study the effect on endothelial cell counts using the Tan EndoGlide has been evaluated. The investigators report a 15.6% of endothelial cell loss 12 months after DSAEK surgery. There are no published studies regarding the Endosaver injector, nevertheless, preliminary results indicate poorer outcome (30% cell loss after one month). No study comparing the two devices in regard to endothelial cell loss was reported so far.

The purpose of this study is to compare the Tan EndoGlide with the new Endosaver 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 postoperatively. Our study would involve prospectively examining a total of 42 subjects (21 eyes with the Tan EndoGlide and 21 eyes with the Endosaver injector) and compare endothelial cell loss and visual outcomes between groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients presenting with corneal decompensation requiring DSAEK with or without cataract surgery for visual rehabilitation.

• Clinical diagnosis include endothelial cell dysfunction secondary to Fuchs endothelial dystrophy, pseudophakic or aphakic bullous keratopathy, failed penetrating keratoplasty or DSAEK, iridocorneal endothelial syndrome or trauma.

• Ability to understand the nature of the procedure and give full informed consent.

• Patients who are able to comply with the standard DSAEK follow-up protocol at the Toronto Western Hospital.

Exclusion Criteria:

• Patients with late stage corneal decompensation with stromal scarring unsuitable for DSAEK and therefore requiring penetrating keratoplasty.

• Patients with complex anterior segment pathology precluding successful DSAEK procedure.

• Patients not giving full informed consent to participate in the trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bullous Keratopathy, Unspecified Eye
• Fuch's Endothelial Dystrophy
• Fuchs' Endothelial Dystrophy

Intervention

Device:
• Tan Endoglide
Patients assigned to this intervention will have their endothelial donor graft injected into the anterior chamber using the Tan Endoglide
• Endosaver
Patients assigned to this intervention will have their endothelial donor graft injected into the anterior chamber using the Tan Endoglide

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial cell count after 6 months and 12 months	The patients will be evaluated for endothelial cell loss 6 and 12 post surgery	6,12 months post op	Yes
Secondary	Visual acuity	The patients will be evaluated for Visual acuity stability/improvement at the previous mentioned intervals.	1 month and 3,6,12 months post surgery	Yes