Clinical trial NCT02020044: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Fuchs' Endothelial Corneal Dystrophy
Bullous Keratopathy
Iridocorneal Endothelial Syndrome
Posterior Polymorphous Dystrophy
Endothelial Dysfunction
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Visual acuity (change from baseline)
timeFrame: 1, 3, 6, and 12 months and annually
Secondary outcomes:
measure: Endothelial cell density (change from baseline)
timeFrame: 1, 3, 6, and 12 months and annually
measure: Intraocular pressure (change from baseline)
timeFrame: 1, 3, 6, and 12 months and annually
measure: Manifest refraction (change from baseline)
timeFrame: 1, 3, 6, 12 months and annually
measure: corneal pachymetry (change from baseline)
timeFrame: 1, 3, 6, 12 months and annually
measure: Quality of Life, NEI-VFQ 25 (change from baseline)
timeFrame: 3, 12 months, annualy
measure: corneal topography (change from baseline)
timeFrame: 1, 3, 6, and 12 months and annually
measure: Anterior Segment OCT of cornea and anterior chamber angle (change from baseline)
timeFrame: 1, 3, 6, and 12 months and annually
measure: postoperative Medication (change from baseline)
timeFrame: 1,3,6 and 12 months and annually
measure: Histological Sample of Recipient's Descemet Membrane
timeFrame: intraoperative
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Ophthalmology, Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Department of Ophthalmology, Charité - Unviersitätsmedizin Berlin
name: Necip Torun, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.