Clinical trial NCT01791075: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Fuch's Endothelial Dystrophy
Bullous Keratopathy, Unspecified Eye
Keywords: DSAEK
Tan Endoglide
Endosaver/Endoserter
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2013-02-13
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Endothelial cell count after 6 months and 12 months
timeFrame: 6,12 months post op
Secondary outcomes:
measure: Visual acuity
timeFrame: 1 month and 3,6,12 months post surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: TWH - UHN
name: David S. Rootman, MD
role: PRINCIPAL_INVESTIGATOR
References: