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Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

Primary Purpose

Fuchs' Endothelial Corneal Dystrophy, Bullous Keratopathy, Iridocorneal Endothelial Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Endothelial Keratoplasty
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fuchs' Endothelial Corneal Dystrophy

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female aged 18 or older
  • Scheduled to undergo endothelial keratoplasty
  • Able to provide written informed consent.

Exclusion Criteria:

  • Age less than 18 years

Sites / Locations

  • Department of Ophthalmology, Charité - Universitätsmedizin BerlinRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Endothelial Keratoplasty

Arm Description

Descemet membrane endothelial keratoplasty DMEK Ultra-thin Descemet stripping automated endothelial keratoplasty Ultra-thin DSAEK

Outcomes

Primary Outcome Measures

Visual acuity (change from baseline)

Secondary Outcome Measures

Endothelial cell density (change from baseline)
Intraocular pressure (change from baseline)
Manifest refraction (change from baseline)
corneal pachymetry (change from baseline)
Quality of Life, NEI-VFQ 25 (change from baseline)
Questionnaire
corneal topography (change from baseline)
Anterior Segment OCT of cornea and anterior chamber angle (change from baseline)
postoperative Medication (change from baseline)
Histological Sample of Recipient's Descemet Membrane
Recipient's Descemet Membrane

Full Information

First Posted
December 11, 2013
Last Updated
December 18, 2013
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02020044
Brief Title
Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
Official Title
Prospective Clinical Study on Postoperative Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is evaluate the outcome after posterior lamellar keratoplasty (DMEK and Ultra-thin DSAEK) for corneal transplantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs' Endothelial Corneal Dystrophy, Bullous Keratopathy, Iridocorneal Endothelial Syndrome, Posterior Polymorphous Dystrophy, Endothelial Dysfunction

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Endothelial Keratoplasty
Arm Type
Other
Arm Description
Descemet membrane endothelial keratoplasty DMEK Ultra-thin Descemet stripping automated endothelial keratoplasty Ultra-thin DSAEK
Intervention Type
Other
Intervention Name(s)
Endothelial Keratoplasty
Other Intervention Name(s)
DMEK, Descemet Membrane Endothelial Keratoplasty, Ultra-thin Descemet stripping automated endothelial keratoplasty, Ultra-thin DSAEK
Primary Outcome Measure Information:
Title
Visual acuity (change from baseline)
Time Frame
1, 3, 6, and 12 months and annually
Secondary Outcome Measure Information:
Title
Endothelial cell density (change from baseline)
Time Frame
1, 3, 6, and 12 months and annually
Title
Intraocular pressure (change from baseline)
Time Frame
1, 3, 6, and 12 months and annually
Title
Manifest refraction (change from baseline)
Time Frame
1, 3, 6, 12 months and annually
Title
corneal pachymetry (change from baseline)
Time Frame
1, 3, 6, 12 months and annually
Title
Quality of Life, NEI-VFQ 25 (change from baseline)
Description
Questionnaire
Time Frame
3, 12 months, annualy
Title
corneal topography (change from baseline)
Time Frame
1, 3, 6, and 12 months and annually
Title
Anterior Segment OCT of cornea and anterior chamber angle (change from baseline)
Time Frame
1, 3, 6, and 12 months and annually
Title
postoperative Medication (change from baseline)
Time Frame
1,3,6 and 12 months and annually
Title
Histological Sample of Recipient's Descemet Membrane
Description
Recipient's Descemet Membrane
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged 18 or older Scheduled to undergo endothelial keratoplasty Able to provide written informed consent. Exclusion Criteria: Age less than 18 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna-Karina Maier, MD
Email
anna-karina.maier@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Necip Torun, MD
Organizational Affiliation
Department of Ophthalmology, Charité - Unviersitätsmedizin Berlin
Official's Role
Study Director
Facility Information:
Facility Name
Department of Ophthalmology, Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna-Karina Maier, MD
Phone
+4930450654419
Email
anna-karina.maier@charite.de
First Name & Middle Initial & Last Name & Degree
Anna-Karina Maier, MD
First Name & Middle Initial & Last Name & Degree
Necip Torun, MD
First Name & Middle Initial & Last Name & Degree
Johannes Gonnermann, MD
First Name & Middle Initial & Last Name & Degree
Mathias KJ Klamann, MD
First Name & Middle Initial & Last Name & Degree
Tobias Brockmann, MD
First Name & Middle Initial & Last Name & Degree
Enken Gundlach, MD
First Name & Middle Initial & Last Name & Degree
Christian Eulufi, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
23928950
Citation
Maier AK, Gundlach E, Gonnermann J, Klamann MK, Eulufi C, Bertelmann E, Joussen AM, Torun N. Fellow Eye Comparison of Descemet Membrane Endothelial Keratoplasty and Penetrating Keratoplasty. Cornea. 2013 Oct;32(10):1344-8. doi: 10.1097/ICO.0b013e31829dd816.
Results Reference
background
PubMed Identifier
23575642
Citation
Maier AK, Gundlach E, Klamann MK, Gonnermann J, Bertelmann E, Joussen AM, Torun N, Rieck PW. [Influence of donor lamella thickness on visual acuity after Descemet's stripping automated endothelial keratoplasty (DSAEK)]. Ophthalmologe. 2014 Feb;111(2):128-34. doi: 10.1007/s00347-013-2795-0. German.
Results Reference
background
PubMed Identifier
23180233
Citation
Maier AK, Klamann MK, Torun N, Gonnermann J, Schroeter J, Joussen AM, Rieck P. Intraocular pressure elevation and post-DSEK glaucoma after Descemet;s stripping endothelial keratoplasty. Graefes Arch Clin Exp Ophthalmol. 2013 Apr;251(4):1191-8. doi: 10.1007/s00417-012-2203-5. Epub 2012 Nov 20.
Results Reference
background
PubMed Identifier
21872938
Citation
Guerra FP, Anshu A, Price MO, Giebel AW, Price FW. Descemet's membrane endothelial keratoplasty: prospective study of 1-year visual outcomes, graft survival, and endothelial cell loss. Ophthalmology. 2011 Dec;118(12):2368-73. doi: 10.1016/j.ophtha.2011.06.002. Epub 2011 Aug 27.
Results Reference
background
PubMed Identifier
23108011
Citation
van Dijk K, Ham L, Tse WH, Liarakos VS, Quilendrino R, Yeh RY, Melles GR. Near complete visual recovery and refractive stability in modern corneal transplantation: Descemet membrane endothelial keratoplasty (DMEK). Cont Lens Anterior Eye. 2013 Feb;36(1):13-21. doi: 10.1016/j.clae.2012.10.066. Epub 2012 Oct 26.
Results Reference
background
PubMed Identifier
33591041
Citation
Gundlach E, Pilger D, Brockmann T, Dietrich-Ntoukas T, Joussen AM, Torun N, Maier AB. Recovery of Contrast Sensitivity After Descemet Membrane Endothelial Keratoplasty. Cornea. 2021 Sep 1;40(9):1110-1116. doi: 10.1097/ICO.0000000000002686.
Results Reference
derived
PubMed Identifier
32705337
Citation
Gundlach E, Spiller N, Pilger D, Dietrich-Ntoukas T, Joussen AM, Torun N, Maier AB. Impact of difficult unfolding and attachment of the graft lamella on the long-term outcome after Descemet membrane endothelial keratoplasty. Graefes Arch Clin Exp Ophthalmol. 2020 Nov;258(11):2459-2465. doi: 10.1007/s00417-020-04852-z. Epub 2020 Jul 23.
Results Reference
derived
PubMed Identifier
26764881
Citation
Maier AK, Gundlach E, Pilger D, Rubsam A, Klamann MK, Gonnermann J, Bertelmann E, Joussen AM, Torun N. Rate and Localization of Graft Detachment in Descemet Membrane Endothelial Keratoplasty. Cornea. 2016 Mar;35(3):308-12. doi: 10.1097/ICO.0000000000000740.
Results Reference
derived
PubMed Identifier
24782475
Citation
Gonnermann J, Maier AK, Klamann MK, Brockmann T, Bertelmann E, Joussen AM, Torun N. Posterior iris-claw aphakic intraocular lens implantation and Descemet membrane endothelial keratoplasty. Br J Ophthalmol. 2014 Sep;98(9):1291-5. doi: 10.1136/bjophthalmol-2014-304948. Epub 2014 Apr 29.
Results Reference
derived

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Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

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