Plasma Rich in Growth Factors in Corneal Endothelial Transplantation
NCT ID: NCT06261346
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-07-12
2026-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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PRGF group
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.
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.
PRGF
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.
Control group
Participants will undergo endothelial keratoplasty procedure. Participants will be followed up for up to 1 year.
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.
Interventions
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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.
PRGF
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
The following special populations will be excluded.
* Adults unable to consent
* Pregnant women
* Prisoners
18 Years
80 Years
ALL
No
Sponsors
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Florida lions eye bank
UNKNOWN
University of Miami
OTHER
Responsible Party
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Alfonso Sabater
Associate Professor of Clinical Ophthalmology
Principal Investigators
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Alfonso L Sabater, MD
Role: PRINCIPAL_INVESTIGATOR
Bascom Palmer Eye Institute
Locations
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Bascom Palmer Eye Institute
Miami, Florida, United States
Price Vision Group
Indianapolis, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20230420
Identifier Type: -
Identifier Source: org_study_id
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