Fuchs' Endothelial Dystrophy, Corneal Edema
Conditions
Brief summary
The purpose of the study is to determine the safety and efficacy of brief intraoperative corneal endothelial graft incubation in plasma rich in growth factors (PRGF) for reducing postoperative endothelial cell loss.
Interventions
PROCEDUREEndothelial keratoplasty
Surgical replacement of the corneal endothelial cell layer (the cell layer lining the inner surface of the cornea) with brief incubation of the donor tissue in PRGF prior to graft implantation. This incubation will be a one time procedure done to the tissue in the operating room. The endothelial keratoplasty is 30-45 minutes.
BIOLOGICALPRGF
Plasma Rich in Growth Factors (PRGF) is a mixture of proteins and growth factors obtained from the blood of the patient. PRGF incubation lasts 15 minutes. It is a one-time procedure performed on the tissue that will be done in the operating room prior to endothelial keratoplasty.
Sponsors
Florida lions eye bank
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* undergoing endothelial keratoplasty (DSEK or DMEK) at the Bascom Palmer Eye Institute or Price Vision Group, using corneal graft tissue within 14 days of preservation
Exclusion criteria
* History of corneal transplantation in the study eye, Best corrected visual acuity (BCVA) worse than 20/40 in the contralateral eye, systemic immunosuppression, previous intraocular surgical procedures (other than cataract surgery) such as glaucoma tubes or silicone oil. The following special populations will be excluded. * Adults unable to consent * Pregnant women * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in endothelial cell percentage | Baseline, 6 months | Central corneal endothelial cell percentage will be assessed by specular microscopy and compared with the baseline donor endothelial cell percentage measured by the provider eye bank to determine endothelial cell changes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corneal endothelial cell density | Up to 12 months | Central corneal endothelial cell density by specular microscopy (cells/millimeter\^2) |
| Change in Endothelial cell density | Baseline, up to 12 months | Change in central corneal endothelial cell density will be assessed by specular microscopy (cells/millimeter\^2) and compared with the baseline donor endothelial cell density reported by the provider eye bank to determine endothelial cell loss |
| Visual acuity measured by snellen chart | Up to 12 months | Participants will have their best corrected visual acuity measured as values expressed using the Snellen chart. |
| Number of re-bubbling for graft attachment | Up to 2 months | The number of air re-injections for graft attachment within the first 2 months will be assessed. |
Countries
United States
Contacts
Primary ContactAlfonso L Sabater, MD
Backup ContactMarianne Price, PhD
Outcome results
None listed