Endothelial Dysfunction Clinical Trial
Official title:
Prospective Clinical Study on Postoperative Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
The purpose of this study is evaluate the outcome after posterior lamellar keratoplasty (DMEK and Ultra-thin DSAEK) for corneal transplantation.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Department of Ophthalmology, Charité - Universitätsmedizin Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual acuity (change from baseline) | 1, 3, 6, and 12 months and annually | No | |
Secondary | Endothelial cell density (change from baseline) | 1, 3, 6, and 12 months and annually | No | |
Secondary | Intraocular pressure (change from baseline) | 1, 3, 6, and 12 months and annually | No | |
Secondary | Manifest refraction (change from baseline) | 1, 3, 6, 12 months and annually | No | |
Secondary | corneal pachymetry (change from baseline) | 1, 3, 6, 12 months and annually | No | |
Secondary | Quality of Life, NEI-VFQ 25 (change from baseline) | Questionnaire | 3, 12 months, annualy | No |
Secondary | corneal topography (change from baseline) | 1, 3, 6, and 12 months and annually | No | |
Secondary | Anterior Segment OCT of cornea and anterior chamber angle (change from baseline) | 1, 3, 6, and 12 months and annually | No | |
Secondary | postoperative Medication (change from baseline) | 1,3,6 and 12 months and annually | No | |
Secondary | Histological Sample of Recipient's Descemet Membrane | Recipient's Descemet Membrane | intraoperative | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02122198 -
Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women
|
N/A | |
Completed |
NCT04156711 -
Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery
|
N/A | |
Recruiting |
NCT06133634 -
Fisetin to Improve Vascular Function in Older Adults
|
Phase 1/Phase 2 | |
Completed |
NCT05872139 -
Role of Mitochondrial-derived Oxidative Stress to Promote Vascular Endothelial Dysfunction in Non-exercisers With Aging
|
N/A | |
Recruiting |
NCT04558450 -
Covid-19 Effects on Arterial Stiffness and Vascular Aging (CARTESIAN)
|
N/A | |
Terminated |
NCT03325933 -
Resistance Training and Cardiometabolic Health
|
N/A | |
Not yet recruiting |
NCT05939934 -
Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal
|
N/A | |
Completed |
NCT02652975 -
Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium
|
N/A | |
Recruiting |
NCT02334839 -
The Association Between Severity of Hypertensive Disorder During Pregnancy and Endothelial Dysfunction
|
N/A | |
Completed |
NCT01775865 -
Targeting Inflammation to Treat Cardiovascular Aging
|
Phase 2 | |
Completed |
NCT01691404 -
Study on the Effects of Epicatechin and Quercetin Supplementation on Vascular Function and Blood Pressure (FLAVO)
|
N/A | |
Terminated |
NCT01412216 -
The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance
|
Phase 2 | |
Completed |
NCT01319344 -
Effect of Eplerenone on Endothelial Function in Metabolic Syndrome
|
Phase 3 | |
Completed |
NCT00848302 -
Endothelial Function in Human Arteries
|
Early Phase 1 | |
Completed |
NCT00990730 -
Atherosclerosis in Rheumatoid Arthritis
|
N/A | |
Completed |
NCT00987974 -
Short Term Statin Treatment and Endothelial Dysfunction Due to Ischemia and Reperfusion Injury
|
Phase 4 | |
Completed |
NCT00532844 -
A Phase 2, Pharmacokinetic (PK) Study of 6R-BH4 Alone or 6R-BH4 With Vitamin C in Subjects With Endothelial Dysfunction
|
Phase 2 | |
Completed |
NCT00376246 -
Effect of Ezetimibe on Flow-mediated Brachial Artery Reactivity in Healthy Subjects
|
Phase 4 | |
Completed |
NCT00775099 -
Combustion Derived Air Pollution and Vascular Function
|
N/A | |
Active, not recruiting |
NCT03388385 -
Acute Effects of Intravenous Iron on Oxidative Stress and Endothelial Dysfunction in Non-dialysis CKD
|
Phase 4 |