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Corneal Dystrophies, HereditaryDMEKNCT00521898

Descemet Membrane Endothelial Keratoplasty (DMEK)

A study testing Descemet Membrane Endothelial Keratoplasty (DMEK) in people with Corneal Dystrophies, Hereditary, run by Netherlands Institute for Innovative Ocular Surgery at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 21 years and older
Conditions the study is for
Corneal Dystrophies, Hereditary
What is being tested?
Descemet Membrane Endothelial Keratoplasty (DMEK)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteNetherlands
Study dates
Feb 2005to Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Corneal endothelial disorders

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Netherlands Institute for Innovative Ocular Surgery

    Rotterdam, 3071 AA

Other trials in Netherlands

About this study

Official title: Prospective Clinical Study on Descemet Membrane Endothelial Keratoplasty (DMEK)

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

Read the detailed description

See above.

Being tested
Descemet Membrane Endothelial Keratoplasty (DMEK)
Keywords
Corneal transplantation, Descemet membrane
Medical subject headings
Corneal Dystrophies, Hereditary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Descemet Membrane Endothelial Keratoplasty (DMEK)Procedure or surgery

Study groups in NCT00521898
Study groupRoleWhat they receive
DMEKExperimentalDMEK as intervention
Receives: Procedure: Descemet Membrane Endothelial Keratoplasty (DMEK)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best spectacle corrected visual acuity

    Measured: 2005-2015

Secondary outcomes (1)

  1. Corneal endothelial cell density

    Measured: 2005-2015

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2007 (estimated)
  2. Study startFeb 2005
  3. Primary completionFeb 2020
  4. Study completionFeb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00521898
Sponsor's protocol ID
NIIOS.2005.14
Acronym
DMEK
Status last verified
Jan 2023
First submitted
24 Aug 2007
Last updated
12 Jan 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31863726

  • 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.

    PubMed 31478948

  • 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.

    PubMed 25439596

  • 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.

    PubMed 32283096

  • 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.

    PubMed 17102683

  • 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.

    PubMed 17102659

  • 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.

    PubMed 22633346

  • 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.

    PubMed 22285014

  • 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.

    PubMed 22084160

  • 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.

    PubMed 21746971

  • 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.

    PubMed 21726849

  • 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.

    PubMed 20679083

  • 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.

    PubMed 19713195

  • 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.

    PubMed 19555921

  • 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.

    PubMed 19442962

Questions about this trial

What is this clinical trial studying?

A study testing Descemet Membrane Endothelial Keratoplasty (DMEK) in people with Corneal Dystrophies, Hereditary, run by Netherlands Institute for Innovative Ocular Surgery at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best spectacle corrected visual acuity (time frame: 2005-2015). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00521898, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.

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