Descemet Membrane Endothelial Keratoplasty (DMEK)

• Sponsor: Netherlands Institute for Innovative Ocular Surgery (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00521898
• Collaborator: Amnitrans Eyebank Rotterdam (Other)
• Enrollment: 100
• Location: 1
• Arm: 1
• Duration (Months): 180
• Patients Per Site Per Month: 0.6

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Corneal Dystrophies, Hereditary	Procedure: Descemet Membrane Endothelial Keratoplasty (DMEK)	N/A

Detailed Description

See above.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Clinical Study on Descemet Membrane Endothelial Keratoplasty (DMEK)
• Study Start Date: Feb 1, 2005
• Anticipated Primary Completion Date: Feb 1, 2020
• Anticipated Study Completion Date: Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DMEK DMEK as intervention	Procedure: Descemet Membrane Endothelial Keratoplasty (DMEK)

Outcome Measures

Primary Outcome Measures

1. Best spectacle corrected visual acuity [2005-2015]

Secondary Outcome Measures

1. Corneal endothelial cell density [2005-2015]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Corneal endothelial disorders

Exclusion Criteria:

• N/A

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Netherlands Institute for Innovative Ocular Surgery	Rotterdam		Netherlands	3071 AA

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GRJ Melles, MD, PhD, Institute Director, Netherlands Institute for Innovative Ocular Surgery
• ClinicalTrials.gov Identifier: NCT00521898
• Other Study ID Numbers: NIIOS.2005.14
• First Posted: Aug 28, 2007
• Last Update Posted: Mar 29, 2018
• Last Verified: Mar 1, 2018

• Keywords provided by GRJ Melles, MD, PhD, Institute Director, Netherlands Institute for Innovative Ocular Surgery: Corneal transplantation, Descemet membrane
• Additional relevant MeSH terms: Corneal Dystrophies, Hereditary

Study Results

No Results Posted as of Mar 29, 2018