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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06261346
- Acronym / sponsor ID
- 20230420
- Conditions
- Fuchs' Endothelial Dystrophy, Corneal Edema
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Beauty of Sight
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRGF group | Experimental | Procedure: Endothelial keratoplasty, Biological: PRGFParticipants 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. |
| Control group | Active comparator | Procedure: Endothelial keratoplastyParticipants will undergo endothelial keratoplasty procedure. Participants will be followed up for up to 1 year. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endothelial keratoplastySurgical 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. | Procedure or surgery | Control group, PRGF group |
| PRGFPlasma 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. | Biological | PRGF group |
Primary outcome
Change in endothelial cell percentage
Time frame: Baseline, 6 months
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.
4 secondary outcomes
Corneal endothelial cell density
Time frame: Up to 12 months
Change in Endothelial cell density
Time frame: Baseline, up to 12 months
Visual acuity measured by snellen chart
Time frame: Up to 12 months
Number of re-bubbling for graft attachment
Time frame: Up to 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Fuchs' Endothelial Dystrophy
Active, not recruitingPhase 3
Descemet Endothelial Thickness Comparison Trial II
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Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
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RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
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The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alfonso L Sabater, MD principal investigator
Bascom Palmer Eye Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alfonso L Sabater, MD (3053266326, asabater@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in endothelial cell percentage (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.