Comparing Endoglide to Endoserter for DSAEK Graft Insertion

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Fuch's Endothelial Dystrophy; Bullous Keratopathy, Unspecified Eye	Device: Tan Endoglide; Device: Endosaver	Not Applicable

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	42 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
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)
Study Start Date :	January 2012
Estimated Primary Completion Date :	January 2014
Estimated Study Completion Date :	January 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Tan Endoglide; Patients assigned to this arm will have their endothelial donor graft injected into the anterior chamber using the Tan Endoglide.	Device: Tan Endoglide; Patients assigned to this intervention will have their endothelial donor graft injected into the anterior chamber using the Tan Endoglide
Active Comparator: Endosaver/serter; Patients assigned to this arm will have their endothelial donor graft injected into the anterior chamber using the Endosaver/serter injector.	Device: Endosaver; Patients assigned to this intervention will have their endothelial donor graft injected into the anterior chamber using the Tan Endoglide; Other Name: Endoserter

Outcome Measures

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Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Uri Elbaz, MD	4163175662	urielbaz@gmail.com

Locations

Canada, Ontario
Toronto Western Hospital	Recruiting
Toronto, Ontario, Canada

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:	David S. Rootman, MD	TWH - UHN

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT01791075 History of Changes
Other Study ID Numbers:	REB 10-0631-B
First Posted:	February 13, 2013
Last Update Posted:	February 15, 2013
Last Verified:	February 2013

Keywords provided by University Health Network, Toronto:

DSAEK; Tan Endoglide; Endosaver/Endoserter

Additional relevant MeSH terms:

Fuchs' Endothelial Dystrophy; Corneal Dystrophies, Hereditary; Corneal Diseases	Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn