Descemet Membrane Endothelial Keratoplasty (DMEK)

Corneal Dystrophies, Hereditary Clinical Trial

— DMEK  

Official title:

Prospective Clinical Study on Descemet Membrane Endothelial Keratoplasty (DMEK)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00521898
• Other study ID #: NIIOS.2005.14
• Status: Completed
• Phase: N/A
• Start date: February 2005
• Est. completion date: February 2020

Study information

• Verified date: January 2023
• Source: Netherlands Institute for Innovative Ocular Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

See above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Corneal endothelial disorders

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Corneal Dystrophies, Hereditary

Intervention

Procedure:
• Descemet Membrane Endothelial Keratoplasty (DMEK)

Locations

Country	Name	City	State
Netherlands	Netherlands Institute for Innovative Ocular Surgery	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Netherlands Institute for Innovative Ocular Surgery	Amnitrans Eyebank Rotterdam

Country where clinical trial is conducted

Netherlands, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best spectacle corrected visual acuity		2005-2015
Secondary	Corneal endothelial cell density		2005-2015