An interventional study of Endothelial keratoplasty and PRGF in Fuchs' Endothelial Dystrophy and Corneal Edema, sponsored by University of Miami. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by University of Miami · Not applicable, Interventional, and Prevention
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.
92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.
Browse Fuchs' Endothelial Dystrophy studies →University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The following special populations will be excluded.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Endothelial keratoplasty · Biological: PRGF
Participants will undergo endothelial keratoplasty procedure. Participants will be followed up for up to 1 year.
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.
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.
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
Corneal endothelial cell density
Central corneal endothelial cell density by specular microscopy (cells/millimeter\^2)
Time frame: Up to 12 months
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
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Oct 2027, 39 months after the start.
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Fuchs' Endothelial Dystrophy →