Descemet Membrane Endothelial Keratoplasty (DMEK) - Full Text View

Sponsor:	Netherlands Institute for Innovative Ocular Surgery
Collaborator:	Amnitrans Eyebank Rotterdam
Information provided by:	Netherlands Institute for Innovative Ocular Surgery
ClinicalTrials.gov Identifier:	NCT00521898

Purpose

To evaluate isolated Descemet membrane transplantation as a refinement of previous advanced techniques for corneal transplantation, like Descemet Stripping Endothelial Keratoplasty (DSEK)

Condition	Intervention
Corneal Dystrophies, Hereditary	Procedure: Descemet Membrane Endothelial Keratoplasty (DMEK)

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Prospective Clinical Study on Descemet Membrane Endothelial Keratoplasty (DMEK)

Resource links provided by NLM:

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome Help Me Understand Genetics

MedlinePlus related topics: Surgery

U.S. FDA Resources

Further study details as provided by Netherlands Institute for Innovative Ocular Surgery:

Primary Outcome Measures:

Best spectacle corrected visual acuity [ Time Frame: 2005-2015 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Corneal endothelial cell density [ Time Frame: 2005-2015 ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	February 2005
Estimated Study Completion Date:	February 2015
Estimated Primary Completion Date:	February 2015 (Final data collection date for primary outcome measure)

Detailed Description:

See above.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Corneal endothelial disorders

Exclusion Criteria:

N/A

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521898

Contacts

Contact: Gerrit R Melles, MD, PhD

+31 10 297 4444

melles@niioc.nl

Locations

Netherlands
Netherlands Institute for Innovative Ocular Surgery	Recruiting
Rotterdam, Netherlands, 3071 AA
Contact: Kim Herders, MSc
Principal Investigator: Gerrit R Melles, MD, PhD
Sub-Investigator: Jacqueline Wees, PhD

Sponsors and Collaborators

Netherlands Institute for Innovative Ocular Surgery

Amnitrans Eyebank Rotterdam

Investigators

Principal Investigator:

Gerrit R Melles, MD, PhD

Netherlands Institute for Innovative Ocular Surgery

More Information

Additional Information:

NIIOS technique - Descemet Membrane Endothelial Keratoplasty (DMEK) This link exits the ClinicalTrials.gov site

NIIOS technique - Descemet Stripping Endothelial Keratoplasty (DSEK) This link exits the ClinicalTrials.gov site

NIIOS technique - Deep Lamellar Endothelial Keratoplasty (DLEK) - Small incision This link exits the ClinicalTrials.gov site

NIIOS technique - Deep Lamellar Endothelial Keratoplasty (DLEK) This link exits the ClinicalTrials.gov site

Publications:

Melles GR, Ong TS, Ververs B, van der Wees J. Descemet membrane endothelial keratoplasty (DMEK). Cornea. 2006 Sep;25(8):987-90.

Melles GR. Posterior lamellar keratoplasty: DLEK to DSEK to DMEK. Cornea. 2006 Sep;25(8):879-81. No abstract available.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Ham L, van Luijk C, Dapena I, Wong TH, Birbal R, van der Wees J, Melles GR. Endothelial cell density after descemet membrane endothelial keratoplasty: 1- to 2-year follow-up. Am J Ophthalmol. 2009 Oct;148(4):521-7. Epub 2009 Jun 25.

Balachandran C, Ham L, Verschoor CA, Ong TS, van der Wees J, Melles GR. Spontaneous corneal clearance despite graft detachment in descemet membrane endothelial keratoplasty. Am J Ophthalmol. 2009 Aug;148(2):227-234.e1. Epub 2009 May 13.

Ham L, Balachandran C, Verschoor CA, van der Wees J, Melles GR. Visual rehabilitation rate after isolated descemet membrane transplantation: descemet membrane endothelial keratoplasty. Arch Ophthalmol. 2009 Mar;127(3):252-5.

Responsible Party:	NIIOS ( G. Melles )
Study ID Numbers:	NIIOS.2005.14
Study First Received:	August 24, 2007
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00521898 History of Changes
Health Authority:	Netherlands: Independent Ethics Committee

Keywords provided by Netherlands Institute for Innovative Ocular Surgery:

Corneal transplantation, Descemet membrane

Additional relevant MeSH terms:

Corneal Diseases
Genetic Diseases, Inborn
Corneal Dystrophies, Hereditary
Eye Diseases
Eye Diseases, Hereditary

ClinicalTrials.gov processed this record on February 08, 2010