Comparison of Corneal Grafts Cultured in Serum-free Versus Corneal Grafts Cultured in Serum Supplemented Culture Media

Pseudophakic Bullous Keratopathy Clinical Trial

— SFM  

Official title:

In Vitro and Clinical Comparison of Corneal Grafts Cultured in Serum Free Medium or Standard Serum Supplemented Medium in Patients With Degeneration of the Corneal Endothelium

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00623584
• Other study ID #: SKC001SFM08
• Status: Not yet recruiting
• Phase: N/A
• First received: February 13, 2008
• Last updated: December 7, 2010
• Start date: April 2011
• Est. completion date: October 2012

Study information

• Verified date: December 2010
• Source: Klinikum Chemnitz gGmbH
• Contact: Katrin Engelmann, MD
• Phone: + 49 371 333 33230
• Email: k.engelmann[@]skc.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the quality of corneal grafts cultured in a serum-free culture medium with a defined composition versus corneal grafts cultured in a standard serum supplemented culture medium transplanted in patients with decompensated corneal dystrophy

Description:

The primary objective of this clinical trial is to test the equivalence of the quality of the corneal grafts cultured under serum free conditions to corneal grafts cultured in the Minimal Essential Medium supplemented with 2% fetal calf serum, based on a parallel comparison of the endothelial cell density of paired corneal grafts deriving from single donors at different time points before and after the grafting procedure. In addition, the safety of the clinical use of corneal grafts cultured in both media will be determined. The graft survival rate during the follow-up period will be quantified in regard to immune mediated graft rejection and non-immune mediated graft failure, as well as the incidence of corneal edema, corneal opacities and corneal neovascularisation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Male and female patients between 50 and 85 years of age

• Clinically proven Fuchs corneal dystrophy or secondary decompensation the corneal endothelium (e. g. after surgical intervention in the anterior segment of the eye)

• Patient informed consent

Exclusion Criteria:

• Previous penetrating keratoplasty

• Corneal neovascularisation

• Pathologic changes in the anterior segment of the eye (anterior / posterior synechiae, uveitis)

• Glaucoma

• Aphakia

• Infectious diseases of the cornea

• Neurodermitis

• Participation of the patient in another clinical trial within the last four weeks that precede the recruitment

• The patient is unlikely to comply with the requirements of the protocol

• Previous or current abuse of medications, narcotics or alcohol

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fuch's Endothelial Dystrophy
• Fuchs' Endothelial Dystrophy
• Pseudophakic Bullous Keratopathy

Intervention

Procedure:
• Corneal transplantation
Full thickness penetrating keratoplasty
• Corneal transplantation
Full thickness penetrating keratoplasty

Locations

Country	Name	City	State
Germany	Augenklinik, Klinikum Chemnitz gGmbH	Chemnitz	Saxony
Germany	Universitäts Augenklinik	Halle (Saale)	Sachsen-Anhalt

Sponsors (3)

Lead Sponsor	Collaborator
Klinikum Chemnitz gGmbH	German Research Foundation, KKS Netzwerk

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Bednarz J, Doubilei V, Wollnik PC, Engelmann K. Effect of three different media on serum free culture of donor corneas and isolated human corneal endothelial cells. Br J Ophthalmol. 2001 Dec;85(12):1416-20. — View Citation

Hempel B, Bednarz J, Engelmann K. Use of a serum-free medium for long-term storage of human corneas. Influence on endothelial cell density and corneal metabolism. Graefes Arch Clin Exp Ophthalmol. 2001 Oct;239(10):801-5. — View Citation

Møller-Pedersen T, Hartmann U, Ehlers N, Engelmann K. Evaluation of potential organ culture media for eye banking using a human corneal endothelial cell growth assay. Graefes Arch Clin Exp Ophthalmol. 2001 Oct;239(10):778-82. — View Citation

Møller-Pedersen T, Hartmann U, Møller HJ, Ehlers N, Engelmann K. Evaluation of potential organ culture media for eye banking using human donor corneas. Br J Ophthalmol. 2001 Sep;85(9):1075-9. — View Citation

Uphoff J, Bednarz J, Engelmann K. [Follow-up of endothelial cell density after perforating keratoplasty. Effect of donor and recipient-related factors]. Ophthalmologe. 2001 Jun;98(6):550-4. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the endothelial cell density of the corneal grafts prior to and after the transplantation procedure		The measurment will be performed prior to and 1, 4, 12, 24, 36, 48 and 60 months after the transplantation	No
Secondary	Secondary study outcomes are immune mediated graft rejection, non-immune mediated graft failure, as well as the incidence of corneal edema, corneal opacities and corneal neovascularisation.		1,4,12, 24, 36, 48 and 60 month after the transplantation	No