Plasma Rich in Growth Factors in Corneal Endothelial Transplantation

Fuchs' Endothelial Dystrophy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06261346
• Other study ID #: 20230420
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: August 30, 2026

Study information

• Verified date: May 2024
• Source: University of Miami
• Contact: Alfonso L Sabater, MD
• Phone: 3053266326
• Email: asabater[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 30, 2026
• Est. primary completion date: August 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Corneal Edema
• Fuchs' Endothelial Dystrophy

Intervention

Procedure:
• Endothelial 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.

Biological:
• PRGF
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.

Locations

Country	Name	City	State
United States	Price Vision Group	Indianapolis	Indiana
United States	Bascom Palmer Eye Institute	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Florida lions eye bank

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in endothelial cell percentage	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.	Baseline, 6 months
Secondary	Corneal endothelial cell density	Central corneal endothelial cell density by specular microscopy (cells/millimeter^2)	Up to 12 months
Secondary	Change in Endothelial cell density	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	Baseline, up to 12 months
Secondary	Visual acuity measured by snellen chart	Participants will have their best corrected visual acuity measured as values expressed using the Snellen chart.	Up to 12 months
Secondary	Number of re-bubbling for graft attachment	The number of air re-injections for graft attachment within the first 2 months will be assessed.	Up to 2 months