Safety and Efficacy of Brief Intraoperative Corneal Endothelial Graft Incubation in Plasma Rich in Growth Factors (PRGF) for Reducing Postoperative Endothelial Cell Loss
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Bascom Palmer Eye Institute
RECRUITING
Miami
Indiana
Price Vision Group
RECRUITING
Indianapolis
Contact Information
Primary
Alfonso L Sabater, MD
asabater@med.miami.edu
3053266326
Backup
Marianne Price, PhD
mprice@cornea.org
317-814-2990
Time Frame
Start Date: 2024-07-12
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 100
Treatments
Experimental: PRGF group
Participants tissue will be incubated in plasma rich in growth factors prior to endothelial keratoplasty procedure. Participants will be followed up for up to 1 year.
Active_comparator: Control group
Participants will undergo endothelial keratoplasty procedure. Participants will be followed up for up to 1 year.
Related Therapeutic Areas
Sponsors
Leads: University of Miami
Collaborators: Florida lions eye bank