NCT Number: NCT06261346
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Bascom Palmer Eye Institute, Miami, Florida, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The following special populations will be excluded.
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.
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.
Time frame: 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.
Time frame: Up to 12 months
Central corneal endothelial cell density by specular microscopy (cells/millimeter^2)
Time frame: 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
Time frame: Up to 12 months
Participants will have their best corrected visual acuity measured as values expressed using the Snellen chart.
Time frame: Up to 2 months
The number of air re-injections for graft attachment within the first 2 months will be assessed.
Contact information is provided by the study sponsor or research team.
Alfonso L Sabater, MD
CONTACT
Marianne Price, PhD
CONTACT
University of Miami
Other
Safety and Efficacy of Brief Intraoperative Corneal Endothelial Graft Incubation in Plasma Rich in Growth Factors (PRGF) for Reducing Postoperative Endothelial Cell Loss
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