NCT00521898

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2007

Completed
12.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

15 years

First QC Date

August 24, 2007

Last Update Submit

January 11, 2023

Conditions

Corneal Dystrophies, Hereditary

Keywords

Corneal transplantation, Descemet membrane

Outcome Measures

Primary Outcomes (1)

  • Best spectacle corrected visual acuity

    2005-2015

Secondary Outcomes (1)

  • Corneal endothelial cell density

    2005-2015

Study Arms (1)

DMEK

EXPERIMENTAL

DMEK as intervention

Procedure: Descemet Membrane Endothelial Keratoplasty (DMEK)

Interventions

Descemet Membrane Endothelial Keratoplasty (DMEK)PROCEDURE
DMEK

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Corneal endothelial disorders

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Netherlands Institute for Innovative Ocular Surgery

Rotterdam, 3071 AA, Netherlands

Location

Related Publications (16)

  • Birbal RS, Baydoun L, Ham L, Miron A, van Dijk K, Dapena I, Jager MJ, Bohringer S, Oellerich S, Melles GRJ. Effect of Surgical Indication and Preoperative Lens Status on Descemet Membrane Endothelial Keratoplasty Outcomes. Am J Ophthalmol. 2020 Apr;212:79-87. doi: 10.1016/j.ajo.2019.12.011. Epub 2019 Dec 18.

    PMID: 31863726BACKGROUND

  • Birbal RS, Ni Dhubhghaill S, Bourgonje VJA, Hanko J, Ham L, Jager MJ, Bohringer S, Oellerich S, Melles GRJ. Five-Year Graft Survival and Clinical Outcomes of 500 Consecutive Cases After Descemet Membrane Endothelial Keratoplasty. Cornea. 2020 Mar;39(3):290-297. doi: 10.1097/ICO.0000000000002120.

    PMID: 31478948BACKGROUND

  • Rodriguez-Calvo-de-Mora M, Quilendrino R, Ham L, Liarakos VS, van Dijk K, Baydoun L, Dapena I, Oellerich S, Melles GR. Clinical outcome of 500 consecutive cases undergoing Descemet's membrane endothelial keratoplasty. Ophthalmology. 2015 Mar;122(3):464-70. doi: 10.1016/j.ophtha.2014.09.004. Epub 2014 Oct 22.

    PMID: 25439596BACKGROUND

  • Vasiliauskaite I, Oellerich S, Ham L, Dapena I, Baydoun L, van Dijk K, Melles GRJ. Descemet Membrane Endothelial Keratoplasty: Ten-Year Graft Survival and Clinical Outcomes. Am J Ophthalmol. 2020 Sep;217:114-120. doi: 10.1016/j.ajo.2020.04.005. Epub 2020 Apr 10.

    PMID: 32283096BACKGROUND

  • Melles GR, Ong TS, Ververs B, van der Wees J. Descemet membrane endothelial keratoplasty (DMEK). Cornea. 2006 Sep;25(8):987-90. doi: 10.1097/01.ico.0000248385.16896.34.

    PMID: 17102683RESULT

  • Melles GR. Posterior lamellar keratoplasty: DLEK to DSEK to DMEK. Cornea. 2006 Sep;25(8):879-81. doi: 10.1097/01.ico.0000243962.60392.4f. No abstract available.

    PMID: 17102659RESULT

  • 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. doi: 10.1016/j.ajo.2012.02.032. Epub 2012 May 23.

    PMID: 22633346DERIVED

  • 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. doi: 10.1016/j.ajo.2011.10.003. Epub 2012 Jan 28.

    PMID: 22285014DERIVED

  • 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. doi: 10.1001/archophthalmol.2011.343. Epub 2011 Nov 14.

    PMID: 22084160DERIVED

  • 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. doi: 10.1001/archophthalmol.2011.195. Epub 2011 Jul 11.

    PMID: 21746971DERIVED

  • 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. doi: 10.1016/j.ajo.2011.03.031. Epub 2011 Jul 2.

    PMID: 21726849DERIVED

  • 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. doi: 10.1136/bjo.2010.186189. Epub 2010 Aug 1. No abstract available.

    PMID: 20679083DERIVED

  • 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. doi: 10.1136/bjo.2009.160945. Epub 2009 Aug 26.

    PMID: 19713195DERIVED

  • 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. doi: 10.1016/j.ajo.2009.04.025. Epub 2009 Jun 25.

    PMID: 19555921DERIVED

  • 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. doi: 10.1016/j.ajo.2009.02.033. Epub 2009 May 13.

    PMID: 19442962DERIVED

  • 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. doi: 10.1001/archophthalmol.2008.619.

    PMID: 19273786DERIVED

MeSH Terms

Conditions

Corneal Dystrophies, Hereditary

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Gerrit R Melles, MD, PhD

    Netherlands Institute for Innovative Ocular Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Institute Director

Study Record Dates

First Submitted

August 24, 2007

First Posted

August 28, 2007

Study Start

February 1, 2005

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations

NL(1)