Health TrialsbyHealthPanel

Plasma Rich in Growth Factors in Corneal Endothelial Transplantation

ConditionsFuchs' Endothelial DystrophyCorneal Edema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Miami

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Adults unable to consent

Pregnant women

Prisoners

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endothelial keratoplasty

    Procedure/Surgery

    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.

  • PRGF

    Biological/Vaccine

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: PRGF groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 6 months

Secondary outcomes

1

Corneal endothelial cell density

Central corneal endothelial cell density by specular microscopy (cells/millimeter\^2)

Time frame
Up to 12 months
2

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

Time frame
Baseline, up to 12 months
3

Visual acuity measured by snellen chart

Participants will have their best corrected visual acuity measured as values expressed using the Snellen chart.

Time frame
Up to 12 months
4

Number of re-bubbling for graft attachment

The number of air re-injections for graft attachment within the first 2 months will be assessed.

Time frame
Up to 2 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Beauty of Sight

Collaborator

Source ClinicalTrials.gov
Apply now