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Descemet Membrane Endothelial Keratoplasty (DMEK) (DMEK)

Primary Purpose

Corneal Dystrophies, Hereditary

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Descemet Membrane Endothelial Keratoplasty (DMEK)
Sponsored by
Netherlands Institute for Innovative Ocular Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Dystrophies, Hereditary focused on measuring Corneal transplantation, Descemet membrane

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Corneal endothelial disorders

Exclusion Criteria:

  • N/A

Sites / Locations

  • Netherlands Institute for Innovative Ocular Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DMEK

Arm Description

DMEK as intervention

Outcomes

Primary Outcome Measures

Best spectacle corrected visual acuity

Secondary Outcome Measures

Corneal endothelial cell density

Full Information

First Posted
August 24, 2007
Last Updated
January 11, 2023
Sponsor
Netherlands Institute for Innovative Ocular Surgery
Collaborators
Amnitrans Eyebank Rotterdam
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1. Study Identification

Unique Protocol Identification Number
NCT00521898
Brief Title
Descemet Membrane Endothelial Keratoplasty (DMEK)
Acronym
DMEK
Official Title
Prospective Clinical Study on Descemet Membrane Endothelial Keratoplasty (DMEK)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Netherlands Institute for Innovative Ocular Surgery
Collaborators
Amnitrans Eyebank Rotterdam

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate isolated Descemet membrane transplantation as a refinement of previous advanced techniques for corneal transplantation, like Descemet Stripping Endothelial Keratoplasty (DSEK)
Detailed Description
See above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Dystrophies, Hereditary
Keywords
Corneal transplantation, Descemet membrane

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DMEK
Arm Type
Experimental
Arm Description
DMEK as intervention
Intervention Type
Procedure
Intervention Name(s)
Descemet Membrane Endothelial Keratoplasty (DMEK)
Primary Outcome Measure Information:
Title
Best spectacle corrected visual acuity
Time Frame
2005-2015
Secondary Outcome Measure Information:
Title
Corneal endothelial cell density
Time Frame
2005-2015

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Corneal endothelial disorders Exclusion Criteria: N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerrit R Melles, MD, PhD
Organizational Affiliation
Netherlands Institute for Innovative Ocular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Netherlands Institute for Innovative Ocular Surgery
City
Rotterdam
ZIP/Postal Code
3071 AA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
31863726
Citation
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.
Results Reference
background
PubMed Identifier
31478948
Citation
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.
Results Reference
background
PubMed Identifier
25439596
Citation
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.
Results Reference
background
PubMed Identifier
32283096
Citation
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.
Results Reference
background
PubMed Identifier
17102683
Citation
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.
Results Reference
result
PubMed Identifier
17102659
Citation
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.
Results Reference
result
PubMed Identifier
22633346
Citation
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.
Results Reference
derived
PubMed Identifier
22285014
Citation
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.
Results Reference
derived
PubMed Identifier
22084160
Citation
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.
Results Reference
derived
PubMed Identifier
21746971
Citation
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.
Results Reference
derived
PubMed Identifier
21726849
Citation
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.
Results Reference
derived
PubMed Identifier
20679083
Citation
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.
Results Reference
derived
PubMed Identifier
19713195
Citation
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.
Results Reference
derived
PubMed Identifier
19555921
Citation
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.
Results Reference
derived
PubMed Identifier
19442962
Citation
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.
Results Reference
derived
PubMed Identifier
19273786
Citation
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.
Results Reference
derived

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Descemet Membrane Endothelial Keratoplasty (DMEK)

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