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

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

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

Study Overview

• Status: Unknown
• Conditions: Pseudophakic Bullous Keratopathy; Fuch's Endothelial Dystrophy
• Intervention / Treatment: Procedure: Corneal transplantation

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katrin Engelmann, MD; Phone Number: + 49 371 333 33230; Email: k.engelmann@skc.de
• Study Contact Backup: Name: Simo Murovski, MD; Phone Number: + 49 371 6000020; Email: s.murovski@poliklinik-chemnitz.de

Study Locations

• Germany
  • Sachsen-Anhalt
    • Halle (Saale), Sachsen-Anhalt, Germany, 06120
      • Universitäts Augenklinik
      • Contact: Gernot Duncker, MD; Phone Number: +49 345 557 1878; Email: gernot.duncker@medizin.uni-halle.de
      • Contact: Timm Bredehorn, MD; Phone Number: + 49 345 557 1575; Email: timm.bredehorn@dso.de
  • Saxony
    • Chemnitz, Saxony, Germany, 091116
      • Augenklinik, Klinikum Chemnitz gGmbH
      • Contact: Katrin Engelmann, MD; Phone Number: + 49 371 333 33230; Email: k.engelmann@skc.de
      • Contact: Simo Murovski, MD; Phone Number: + 49 371 6000020; Email: s.murovski@poliklinik-chemnitz.de
      • Principal Investigator: Katrin Engelmann, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Patients in this arm randomly receive a corneal graft cultured in a serum free culture medium	Procedure: Corneal transplantation; Full thickness penetrating keratoplasty
Active Comparator: 2; Patients in this arm randomly receive a corneal graft cultured in a serum supplemented culture medium	Procedure: Corneal transplantation; Full thickness penetrating keratoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Klinikum Chemnitz gGmbH
• Collaborators: German Research Foundation; KKS Netzwerk
• Investigators: Principal Investigator: Katrin Engelmann, MD, Klinikum Chemnitz GmbH

Publications and helpful links

General Publications

• 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. doi: 10.1007/s004170100364.
• 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. doi: 10.1136/bjo.85.12.1416.
• 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. doi: 10.1007/s003470170117. German.
• Moller-Pedersen T, Hartmann U, Moller 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. doi: 10.1136/bjo.85.9.1075.
• Moller-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. doi: 10.1007/s004170100354.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): April 1, 2012
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: February 13, 2008
• First Submitted That Met QC Criteria: February 25, 2008
• First Posted (Estimate): February 26, 2008

Study Record Updates

• Last Update Posted (Estimate): December 8, 2010
• Last Update Submitted That Met QC Criteria: December 7, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: corneal transplantation; culture media; penetrating keratoplasty; corneal grafting; corneal grafts; corneal culturing; in vitro culturing
• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Diseases; Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy
• Other Study ID Numbers: SKC001SFM08