Fuchs' Endothelial DystrophyNCT06261346
Plasma Rich in Growth Factors in Corneal Endothelial Transplantation
A study testing Endothelial keratoplasty and PRGF in people with Fuchs' Endothelial Dystrophy and Corneal Edema, run by University of Miami at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fuchs' Endothelial Dystrophy, Corneal Edema
- What is being tested?
- Endothelial keratoplasty and PRGF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jul 2024to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Price Vision Group
Indianapolis, Indiana, 46260
Marianne Price, PhD, 317-814-2990, mprice@cornea.org
Marianne Price, PhD
- Recruiting
Bascom Palmer Eye Institute
Miami, Florida, 33136
Alfonso L Sabater, MD, 305-326-6326, asabater@med.miami.edu
Alfonso L Sabater, MD
About this study
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
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.
- Conditions
- Fuchs' Endothelial Dystrophy, Corneal Edema
- Being tested
- Endothelial keratoplasty, PRGF
- Medical subject headings
- Fuchs' Endothelial Dystrophy, Corneal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endothelial keratoplastyProcedure or 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.
PRGFBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| PRGF group | Experimental | 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. Receives: Procedure: Endothelial keratoplasty; Biological: PRGF |
| Control group | Active comparator | Participants will undergo endothelial keratoplasty procedure. Participants will be followed up for up to 1 year. Receives: Procedure: Endothelial keratoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months
Secondary outcomes (4)
Corneal endothelial cell density
Central corneal endothelial cell density by specular microscopy (cells/millimeter^2)
Measured: 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
Measured: 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.
Measured: 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.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start15 Jul 2024
- Primary completion30 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuchs' Endothelial DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Beauty of Sight
- Responsible party
- Principal investigator, Alfonso Sabater, University of Miami
- Investigators
- Alfonso L Sabater, MD, Principal investigator, Bascom Palmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261346
- Sponsor's protocol ID
- 20230420
- Status last verified
- Apr 2026
- First submitted
- 7 Feb 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No