Comparing Endoglide to Endoserter for DSAEK Graft Insertion

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01791075
First received: February 11, 2013
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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 Intervention
Fuch's Endothelial Dystrophy
Bullous Keratopathy, Unspecified Eye
Device: Tan Endoglide
Device: Endosaver

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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)

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Endothelial cell count after 6 months and 12 months [ Time Frame: 6,12 months post op ] [ Designated as safety issue: Yes ]
    The patients will be evaluated for endothelial cell loss 6 and 12 post surgery


Secondary Outcome Measures:
  • Visual acuity [ Time Frame: 1 month and 3,6,12 months post surgery ] [ Designated as safety issue: Yes ]
    The patients will be evaluated for Visual acuity stability/improvement at the previous mentioned intervals.


Estimated Enrollment: 42
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01791075

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

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01791075     History of Changes
Other Study ID Numbers: REB 10-0631-B
Study First Received: February 11, 2013
Last Updated: February 13, 2013
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on September 14, 2014