Comparing Endoglide to Endoserter for DSAEK Graft Insertion
Primary Purpose
Fuch's Endothelial Dystrophy, Bullous Keratopathy, Unspecified Eye
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Tan Endoglide
Endosaver
Sponsored by
About this trial
This is an interventional treatment trial for Fuch's Endothelial Dystrophy focused on measuring DSAEK, Tan Endoglide, Endosaver/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
Sites / Locations
- Toronto Western HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Tan Endoglide
Endosaver/serter
Arm Description
Patients assigned to this arm will have their endothelial donor graft injected into the anterior chamber using the Tan Endoglide.
Patients assigned to this arm will have their endothelial donor graft injected into the anterior chamber using the Endosaver/serter injector.
Outcomes
Primary Outcome Measures
Endothelial cell count after 6 months and 12 months
The patients will be evaluated for endothelial cell loss 6 and 12 post surgery
Secondary Outcome Measures
Visual acuity
The patients will be evaluated for Visual acuity stability/improvement at the previous mentioned intervals.
Full Information
NCT ID
NCT01791075
First Posted
February 11, 2013
Last Updated
February 13, 2013
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT01791075
Brief Title
Comparing Endoglide to Endoserter for DSAEK Graft Insertion
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 Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuch's Endothelial Dystrophy, Bullous Keratopathy, Unspecified Eye
Keywords
DSAEK, Tan Endoglide, Endosaver/Endoserter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tan Endoglide
Arm Type
Active Comparator
Arm Description
Patients assigned to this arm will have their endothelial donor graft injected into the anterior chamber using the Tan Endoglide.
Arm Title
Endosaver/serter
Arm Type
Active Comparator
Arm Description
Patients assigned to this arm will have their endothelial donor graft injected into the anterior chamber using the Endosaver/serter injector.
Intervention Type
Device
Intervention Name(s)
Tan Endoglide
Intervention Description
Patients assigned to this intervention will have their endothelial donor graft injected into the anterior chamber using the Tan Endoglide
Intervention Type
Device
Intervention Name(s)
Endosaver
Other Intervention Name(s)
Endoserter
Intervention Description
Patients assigned to this intervention will have their endothelial donor graft injected into the anterior chamber using the Tan Endoglide
Primary Outcome Measure Information:
Title
Endothelial cell count after 6 months and 12 months
Description
The patients will be evaluated for endothelial cell loss 6 and 12 post surgery
Time Frame
6,12 months post op
Secondary Outcome Measure Information:
Title
Visual acuity
Description
The patients will be evaluated for Visual acuity stability/improvement at the previous mentioned intervals.
Time Frame
1 month and 3,6,12 months post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Uri Elbaz, MD
Phone
4163175662
Email
urielbaz@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S. Rootman, MD
Organizational Affiliation
TWH - UHN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Comparing Endoglide to Endoserter for DSAEK Graft Insertion
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