RECRUITING

Plasma Rich in Growth Factors in Corneal Endothelial Transplantation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Safety and Efficacy of Brief Intraoperative Corneal Endothelial Graft Incubation in Plasma Rich in Growth Factors (PRGF) for Reducing Postoperative Endothelial Cell Loss

Quick Facts

Study Start:2024-07-12
Study Completion:2026-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06261346

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  1. * 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.
  2. * Adults unable to consent
  3. * Pregnant women
  4. * Prisoners

Contacts and Locations

Study Contact

Alfonso L Sabater, MD
CONTACT
3053266326
asabater@med.miami.edu
Marianne Price, PhD
CONTACT
317-814-2990
mprice@cornea.org

Principal Investigator

Alfonso L Sabater, MD
PRINCIPAL_INVESTIGATOR
Bascom Palmer Eye Institute

Study Locations (Sites)

Bascom Palmer Eye Institute
Miami, Florida, 33136
United States
Price Vision Group
Indianapolis, Indiana, 46260
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Alfonso L Sabater, MD, PRINCIPAL_INVESTIGATOR, Bascom Palmer Eye Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-12
Study Completion Date2026-10-30

Study Record Updates

Study Start Date2024-07-12
Study Completion Date2026-10-30

Terms related to this study

Additional Relevant MeSH Terms

  • Fuchs' Endothelial Dystrophy
  • Corneal Edema