NCT06261346

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Jul 2024Dec 2027

First Submitted

Initial submission to the registry

February 7, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

February 7, 2024

Last Update Submit

April 3, 2026

Conditions

Corneal EdemaFuchs' Endothelial Dystrophy

Outcome Measures

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.

    Baseline, 6 months

Secondary Outcomes (4)

  • Corneal endothelial cell density

    Up to 12 months

  • Change in Endothelial cell density

    Baseline, up to 12 months

  • Visual acuity measured by snellen chart

    Up to 12 months

  • Number of re-bubbling for graft attachment

    Up to 2 months

Study Arms (2)

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.

Procedure: Endothelial keratoplastyBiological: PRGF

Control group

ACTIVE COMPARATOR

Participants will undergo endothelial keratoplasty procedure. Participants will be followed up for up to 1 year.

Procedure: Endothelial keratoplasty

Interventions

Endothelial keratoplastyPROCEDURE

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.

Control groupPRGF group
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.

PRGF group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

RECRUITING

Price Vision Group

Indianapolis, Indiana, 46260, United States

RECRUITING

MeSH Terms

Conditions

Fuchs' Endothelial DystrophyCorneal Edema

Interventions

Descemet Stripping Endothelial Keratoplasty

Condition Hierarchy (Ancestors)

Corneal Dystrophies, HereditaryCorneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsCorneal TransplantationRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeTransplantation

Study Officials

  • Alfonso L Sabater, MD

    Bascom Palmer Eye Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfonso L Sabater, MD

CONTACT

3053266326asabater@med.miami.edu

Marianne Price, PhD

CONTACT

317-814-2990mprice@cornea.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Ophthalmology

Study Record Dates

First Submitted

February 7, 2024

First Posted

February 15, 2024

Study Start

July 15, 2024

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)