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

NCT00623584 | Unknown DMC

• 1 other identifier: SKC001SFM08
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Fuch's Endothelial Dystrophy; Pseudophakic Bullous Keratopathy

Keywords

penetrating keratoplasty; corneal transplantation; corneal grafting; corneal grafts; culture media; corneal culturing; in vitro culturing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

Patients in this arm randomly receive a corneal graft cultured in a serum free culture medium

Procedure: Corneal transplantation

2

ACTIVE COMPARATOR

Patients in this arm randomly receive a corneal graft cultured in a serum supplemented culture medium

Procedure: Corneal transplantation

Interventions

Corneal transplantation PROCEDURE

Full thickness penetrating keratoplasty

1

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Klinikum Chemnitz gGmbH: lead
• German Research Foundation: collaborator
• KKS Netzwerk: collaborator

Study Sites (2)

Augenklinik, Klinikum Chemnitz gGmbH

Chemnitz, Saxony, 091116, Germany

Location

Universitäts Augenklinik

Halle, Saxony-Anhalt, 06120, Germany

Location

Related Publications (5)

• 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.

  PMID: 11760044 BACKGROUND

• 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.

  PMID: 11734511 BACKGROUND

• 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.

  PMID: 11450479 BACKGROUND

• 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.

  PMID: 11520760 BACKGROUND

• 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.

  PMID: 11760040 BACKGROUND

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Interventions

Corneal Transplantation

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Katrin Engelmann, MD

  Klinikum Chemnitz GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrin Engelmann, MD

CONTACT

+ 49 371 333 33230; k.engelmann@skc.de

Simo Murovski, MD

CONTACT

+ 49 371 6000020; s.murovski@poliklinik-chemnitz.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 13, 2008
• First Posted: February 26, 2008
• Study Start: April 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 8, 2010

Record last verified: 2010-12

Locations

DE (2)