Plasma Rich in Growth Factors in Corneal Endothelial Transplantation

University of Miami

Status: Enrolling

Conditions: Corneal Edema; Fuchs' Endothelial Dystrophy

Treatments: Procedure: Endothelial keratoplasty; Biological: PRGF

Study type: Interventional

Funder types: Other

Identifiers

NCT06261346

20230420

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

PRGF group

Experimental group

Description:

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.

Treatment:

Biological: PRGF

Procedure: Endothelial keratoplasty

Control group

Active Comparator group

Description:

Participants will undergo endothelial keratoplasty procedure. Participants will be followed up for up to 1 year.

Treatment:

Procedure: Endothelial keratoplasty