Plasma Rich in Growth Factors in Corneal Endothelial Transplantation

Fuchs' Endothelial Dystrophy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06261346
• Other study ID #: 20230420
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: Price Vision Group
• Contact: Marianne Price, PhD
• Phone: 317-814-2990
• Email: mprice[@]cornea.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Subjects scheduled for endothelial keratoplasty will be enrolled and randomized to have the graft incubated in PRGF or not prior to graft implantation. The main outcome is the percentage central corneal endothelial cell loss 6 months after surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• History of corneal transplantation in the study eye, 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

Related Conditions & MeSH terms

• Corneal Edema
• Fuchs' Endothelial Dystrophy

Intervention

Procedure:
• PRGF
Endothelial keratoplasty with brief incubation of the donor tissue in PRGF prior to graft implantation

Locations

Country	Name	City	State
United States	Price Vision Group	Indianapolis	Indiana
United States	Bascom Palmer Eye Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Price Vision Group

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bhogal M, Balda MS, Matter K, Allan BD. Global cell-by-cell evaluation of endothelial viability after two methods of graft preparation in Descemet membrane endothelial keratoplasty. Br J Ophthalmol. 2016 Apr;100(4):572-8. doi: 10.1136/bjophthalmol-2015-30 — View Citation

Cho KS, Lee EH, Choi JS, Joo CK. Reactive oxygen species-induced apoptosis and necrosis in bovine corneal endothelial cells. Invest Ophthalmol Vis Sci. 1999 Apr;40(5):911-9. — View Citation

Ishii N, Yamaguchi T, Yazu H, Satake Y, Yoshida A, Shimazaki J. Factors associated with graft survival and endothelial cell density after Descemet's stripping automated endothelial keratoplasty. Sci Rep. 2016 Apr 28;6:25276. doi: 10.1038/srep25276. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial cell loss at 6 months	Central corneal endothelial cell density will be assessed by specular microscopy and compared with the baseline donor endothelial cell density measured by the provider eye bank to determine endothelial cell loss	6 months
Secondary	Corneal endothelial cell density	Central corneal endothelial cell density by specular microscopy	1, 3 and 12 months
Secondary	Endothelial cell loss	central corneal endothelial cell density will be assessed by specular microscopy and compared with the baseline donor endothelial cell density reported by the provider eye bank to determine endothelial cell loss	1, 3 and 12 months
Secondary	Best corrected visual acuity	Best corrected visual acuity will be assess with ETDRS charts	1 month
Secondary	Re-bubble rate	The incidence of air re-injection to promote graft attachment within the first 2 months will be assessed	2 months