Endothelial Cell Loss With Different Insertion Devices
Conditions
Brief summary
The Tan EndoGlide device results in less endothelial cell trauma during insertion of the donor corneal graft indicated by reduced endothelial cell loss at 1 year follow-up compared to the Forceps.
Interventions
DEVICEUse of the Tan Endoglide to insert the donor graft
Using the Tan Endoglide to insert the donor graft into the eye
DEVICEForceps for delivery of the donor graft
Use of the forceps for delivery of the donor graft into the eye.
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Donor Graft Endothelial cell counts | 1 year |
| Best corrected visual acuity | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Complications of surgery | 1 year |
Countries
Canada
Contacts
Primary ContactAllan R Slomovic, MA MD
Outcome results
None listed