Comparing Endoglide to Endoserter for DSAEK Graft Insertion

NCT ID: NCT01791075

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-01-31

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 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.

Conditions

Fuch's Endothelial Dystrophy; Bullous Keratopathy, Unspecified Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tan Endoglide

Patients assigned to this arm will have their endothelial donor graft injected into the anterior chamber using the Tan Endoglide.

Group Type: ACTIVE_COMPARATOR

Tan Endoglide

Intervention Type: DEVICE

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

Endosaver/serter

Patients assigned to this arm will have their endothelial donor graft injected into the anterior chamber using the Endosaver/serter injector.

Group Type: ACTIVE_COMPARATOR

Endosaver

Intervention Type: DEVICE

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

Interventions

Tan Endoglide

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

Intervention Type: DEVICE

Endosaver

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

Intervention Type: DEVICE

Other Intervention Names

Endoserter

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David S. Rootman, MD

Role: PRINCIPAL_INVESTIGATOR

TWH - UHN

Locations

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Uri Elbaz, MD

Role: CONTACT

urielbaz@gmail.com

4163175662

Other Identifiers

REB 10-0631-B

Identifier Type: -

Identifier Source: org_study_id