Cataract Surgery Clinical Trial
Official title:
European Prospective Multicentre, Open Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy (ETCF-trial)
The purpose of this study is to investigate whether there is a difference in best spectacle corrected visual acuity (BSCVA) in patients treated with one of the following two surgeries: (1) cataract surgery with preservation of the diseased endothelial cells ("cataract surgery only experimental intervention, investigational therapy/ arm 1); (2) cataract surgery combined with removal of the diseased endothelial cells and the attached Descemet's membrane followed by transplantation of a healthy endothelial cell layer with attached Descemet's membrane ("triple-DMEK"(""cataract surgery only", control intervention comparator therapy/ arm 2)
After signing the informed consent, patients are screened for eligibility for the trial regarding in- and exclusion criteria. Different tests will be performed like ocular examination including slit lamp examination, fundus examination, IOP measurement, BSCVA, Pentacam imaging, contrast sensivity test and Macula-OCT, vital signs. Once all inclusion criteria and none of the exclusion criteria are met, the patient will be enrolled into the trial and will receive a subject-ID. If Screening and Baseline assessments cannot be performed on the same day, a Baseline Visit can take place up to 7 days after enrolment of the subject into the clinical trial. At the Baseline Visit different tests will be performed like a Fluorescein stain test. In addition, subjects have to complete vision related quality of life questionnaires. After all investigations are completed, the subject will be randomised and distributed to the respective treatment groups. Patients who are enroled in arm 1 undergo exclusively a cataract surgery, in the comparator therapy (arm 2) patients undergo triple-DMEK (cataract surgery and DMEK) The post-operative Visit will take place 22 weeks ± 14 days after the surgical intervention where different test have to be performed. The duration of the clinical trial for every individual subject will be up to 24 weeks. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02573610 -
Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery
|
Phase 3 | |
Completed |
NCT02910362 -
Intra-surgical Evaluation of CATS Tonometer Prism and Abbott Medical Optics Versus Alcon Phacoemulsification Machines
|
N/A | |
Recruiting |
NCT01193504 -
Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification
|
Phase 4 | |
Completed |
NCT01455233 -
2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery
|
Phase 4 | |
Completed |
NCT01199510 -
Efficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery
|
Phase 4 | |
Completed |
NCT04146961 -
The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance
|
||
Completed |
NCT00585975 -
Efficacy and Safety of Bromfenac Ophthalmic Solution
|
Phase 2 | |
Completed |
NCT00406913 -
Prophylaxis Prior to Cataract Surgery Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery
|
N/A | |
Not yet recruiting |
NCT04131335 -
Use of Prophylactic Lubricating Drops After Cataract Surgery
|
N/A | |
Recruiting |
NCT05331690 -
Cataract Surgery and Inflammation - the Role for Preoperative NSAIDs (Pre-CIN)
|
Phase 4 | |
Withdrawn |
NCT04563559 -
PREFERENTIAL Study
|
Phase 2/Phase 3 | |
Completed |
NCT04732351 -
Evaluation of the Active Sentry System During Cataract Surgery With the Centurion Phacoemulsifier
|
||
Completed |
NCT02128113 -
RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD
|
Phase 2 | |
Completed |
NCT03873454 -
The Effects of Music on Perioperative Outcomes in Cataract Surgery
|
N/A | |
Completed |
NCT04769856 -
Impact of Non-fasting on Anxiety in Cataract Surgery
|
N/A | |
Withdrawn |
NCT00604305 -
Comperative Trial Between an Accommodative Iol and Monofocal Iol
|
N/A | |
Completed |
NCT05925894 -
Efficacy Mydrane ® for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma.
|
N/A | |
Not yet recruiting |
NCT06136780 -
Impact of Free Reading Glasses on Work and Visual Function Following Cataract Surgery in Honduras
|
N/A | |
Completed |
NCT04633954 -
Brimonidine for Subconjunctival Hemorrhage From Femtosecond Laser Assisted Cataract Surgery
|
N/A | |
Completed |
NCT03644875 -
Study of Etacoat in Patients With Cataract Surgery Via the Anterior Chamber
|