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

NCT02020044 | Unknown DMC

• 1 other identifier: EA2/108/12
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fuchs' Endothelial Corneal Dystrophy; Bullous Keratopathy; Iridocorneal Endothelial Syndrome; Posterior Polymorphous Dystrophy; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

• Visual acuity (change from baseline)

  1, 3, 6, and 12 months and annually

Secondary Outcomes (9)

• Endothelial cell density (change from baseline)

  1, 3, 6, and 12 months and annually

• Intraocular pressure (change from baseline)

  1, 3, 6, and 12 months and annually

• Manifest refraction (change from baseline)

  1, 3, 6, 12 months and annually

• corneal pachymetry (change from baseline)

  1, 3, 6, 12 months and annually

• Quality of Life, NEI-VFQ 25 (change from baseline)

  3, 12 months, annualy

Study Arms (1)

Endothelial Keratoplasty

OTHER

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

Other: Endothelial Keratoplasty

Interventions

Endothelial Keratoplasty OTHER

Also known as: DMEK, Descemet Membrane Endothelial Keratoplasty, Ultra-thin Descemet stripping automated endothelial keratoplasty, Ultra-thin DSAEK

Endothelial Keratoplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Age less than 18 years

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Department of Ophthalmology, Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 13353, Germany

RECRUITING

Related Publications (9)

• 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.

  PMID: 23928950 BACKGROUND

• 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.

  PMID: 23575642 BACKGROUND

• 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.

  PMID: 23180233 BACKGROUND

• 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.

  PMID: 21872938 BACKGROUND

• 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.

  PMID: 23108011 BACKGROUND

• 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.

  PMID: 33591041 DERIVED

• 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.

  PMID: 32705337 DERIVED

• 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.

  PMID: 26764881 DERIVED

• 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.

  PMID: 24782475 DERIVED

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy; Iridocorneal Endothelial Syndrome

Interventions

Descemet Stripping Endothelial Keratoplasty

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Iris Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Corneal Transplantation; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Necip Torun, MD

  Department of Ophthalmology, Charité - Unviersitätsmedizin Berlin

  STUDY DIRECTOR

Central Study Contacts

Anna-Karina Maier, MD

CONTACT

anna-karina.maier@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Necip, Torun, MD

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 24, 2013
• Study Start: September 1, 2012
• Primary Completion: December 1, 2015
• Last Updated: December 24, 2013

Record last verified: 2013-12

Locations

DE (1)