Descemet Membrane Endothelial Keratoplasty (DMEK)

This study is currently recruiting participants.

Verified October 2012 by Netherlands Institute for Innovative Ocular Surgery

Sponsor:

Collaborator:

Amnitrans Eyebank Rotterdam

Information provided by (Responsible Party):

GRJ Melles, MD, PhD, Netherlands Institute for Innovative Ocular Surgery

ClinicalTrials.gov Identifier:

NCT00521898

First received: August 24, 2007

Last updated: October 30, 2012

Last verified: October 2012

History of Changes

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:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prospective Clinical Study on Descemet Membrane Endothelial Keratoplasty (DMEK)

Resource links provided by NLM:

Genetics Home Reference related topics: lattice corneal dystrophy type I Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome

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:

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 ClinicalTrials.gov Identifier (NCT Number):

Dirisamer M, Yeh RY, van Dijk K, Ham L, Dapena I, Melles GR. Recipient endothelium may relate to corneal clearance in descemet membrane endothelial transfer. Am J Ophthalmol. 2012 Aug;154(2):290-296.e1. Epub 2012 May 23.

Naveiras M, Dirisamer M, Parker J, Ham L, van Dijk K, Dapena I, Melles GR. Causes of glaucoma after descemet membrane endothelial keratoplasty. Am J Ophthalmol. 2012 May;153(5):958-966.e1. Epub 2012 Jan 28.

Dirisamer M, van Dijk K, Dapena I, Ham L, Oganes O, Frank LE, Melles GR. Prevention and management of graft detachment in descemet membrane endothelial keratoplasty. Arch Ophthalmol. 2012 Mar;130(3):280-91. Epub 2011 Nov 14.

Dirisamer M, Ham L, Dapena I, Moutsouris K, Droutsas K, van Dijk K, Frank LE, Oellerich S, Melles GR. Efficacy of descemet membrane endothelial keratoplasty: clinical outcome of 200 consecutive cases after a learning curve of 25 cases. Arch Ophthalmol. 2011 Nov;129(11):1435-43. Epub 2011 Jul 11.

Dirisamer M, Dapena I, Ham L, van Dijk K, Oganes O, Frank LE, van der Wees J, Melles GR. Patterns of corneal endothelialization and corneal clearance after descemet membrane endothelial keratoplasty for fuchs endothelial dystrophy. Am J Ophthalmol. 2011 Oct;152(4):543-555.e1. Epub 2011 Jul 2.

Dapena I, Ham L, Moutsouris K, Melles GR. Incidence of recipient Descemet membrane remnants at the donor-to-stromal interface after descemetorhexis in endothelial keratoplasty. Br J Ophthalmol. 2010 Dec;94(12):1689-90. Epub 2010 Aug 1. No abstract available.

Dapena I, Ham L, van Luijk C, van der Wees J, Melles GR. Back-up procedure for graft failure in Descemet membrane endothelial keratoplasty (DMEK). Br J Ophthalmol. 2010 Feb;94(2):241-4. Epub 2009 Aug 26.

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:	GRJ Melles, MD, PhD, Institute Director, Netherlands Institute for Innovative Ocular Surgery
ClinicalTrials.gov Identifier:	NCT00521898 History of Changes
Other Study ID Numbers:	NIIOS.2005.14
Study First Received:	August 24, 2007
Last Updated:	October 30, 2012
Health Authority:	Netherlands: Independent Ethics Committee

Keywords provided by Netherlands Institute for Innovative Ocular Surgery:

Corneal transplantation, Descemet membrane

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 21, 2013

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