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Fuchs' Endothelial Dystrophy clinical trials

View clinical trials related to Fuchs' Endothelial Dystrophy.

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NCT ID: NCT06425666 Not yet recruiting - Cataract Surgery Clinical Trials

Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy

Start date: June 2024
Phase: N/A
Study type: Interventional

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)

NCT ID: NCT06261346 Not yet recruiting - Clinical trials for Fuchs' Endothelial Dystrophy

Plasma Rich in Growth Factors in Corneal Endothelial Transplantation

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

The purpose of the study is to determine the safety and efficacy of brief intraoperative corneal endothelial graft incubation in plasma rich in growth factors (PRGF) for reducing postoperative endothelial cell loss.

NCT ID: NCT06048380 Recruiting - Cataract Clinical Trials

The Effects of Ripasudil in Patients With FED Undergoing Femtosecond Laser Assisted Cataract Surgery

Start date: October 2023
Phase: Phase 3
Study type: Interventional

The purpose of this research is to investigate the effects of ripasudil administered as an ophthalmic solution in patients with FED after femtosecond laser assisted cataract surgery. The secondary aim is to identity the characteristics of patients who will benefit the most with the use of ripasudil based on the test results obtained from this study.

NCT ID: NCT05853978 Recruiting - Cataract Clinical Trials

The Evaluation of Balanced Salt Solution During Cataract Surgery

Start date: May 2023
Phase: Phase 4
Study type: Interventional

This study aims to identify if the use of BSS PLUS® Sterile Intraocular Irrigating Solution as an irrigation solution leads to improved corneal outcomes vs BSS® Sterile Irrigating Solution in more compromised corneas.

NCT ID: NCT05826353 Recruiting - Clinical trials for Fuchs Endothelial Corneal Dystrophy

A Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)

Start date: May 11, 2023
Phase: Phase 3
Study type: Interventional

A study to assess the safety and efficacy of K-321 in participants with FECD after simultaneous cataract surgery and descemetorhexis.

NCT ID: NCT05795699 Recruiting - Clinical trials for Fuchs Endothelial Corneal Dystrophy

A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)

Start date: March 30, 2023
Phase: Phase 3
Study type: Interventional

A study to assess the safety and efficacy of K-321 in participants with FECD after descemetorhexis.

NCT ID: NCT05716945 Not yet recruiting - Clinical trials for Intraocular Pressure

The OPTIMISE Study

Start date: March 1, 2023
Phase: Phase 4
Study type: Interventional

Rationale: The cornea is the most transplanted tissue in the Netherlands, with more than 1,500 procedures performed each year. A minimally invasive technique called Descemet Membrane Endothelial Keratoplasty (DMEK) has become the preferred method in the past decade. The main advantage of DMEK over previous techniques is a low graft rejection rate (1-2% per year). Despite this, rejection prophylaxis after DMEK follows the same high potency regimen as previous techniques in the first year, and patients are burdened with indefinite immunosuppression. The current project, OPTIMISE, aims to establish an evidence-based, cost-effective regimen that effectively prevents rejection and minimizes side effects. Corticosteroid eye drops are the mainstay of ocular immunomodulatory therapy. Their main side effect is a steroid-induced increase in intraocular pressure (IOP). It manifests in about one-fourth of patients within the first year after surgery and can lead to irreversible optic nerve damage and vision loss. Patients with IOP elevation require additional medications and hospital visits resulting in reduced quality of life and increased costs. The optimal dosing regimen in the first year after DMEK and whether patients may safely stop steroids after one year remains unknown. As a result, protocols in the Netherlands vary considerably from surgeon to surgeon. Patients are potentially over-treated in the short and long-term, resulting in undue burden for the patient and increased costs. Consequently, the Dutch Ophthalmology Society (NOG) identified the optimal short- and long-term immunosuppressive protocol for corneal transplantation as one of its Top 10 knowledge gaps, underscoring relevance for clinical practice. With this work, the investigators expect to address this knowledge gap to the benefit of our patients and society. Objective: The OPTIMISE study aims to establish an evidence-based, cost-effective regimen that effectively prevents rejection and minimizes side effects. The hypothesis of this study is that Fluorometholone 0.1% in the first year and discontinuing medication in the second year is a cost-effective treatment strategy after DMEK. Study design: The design of this study is a randomized, controlled multicentre trial with a duration of 24 months. Study population: The study population will consist of 342 patients aged 21 years or older undergoing DMEK surgery in one eye. Intervention: All patients will receive Descemet's Membrane Endothelial Keratoplasty. Following this procedure, patients will be randomized into the following post-operative regime in two stages: STEP-I (Year 1): Control group: DMS 0.1% 6 times a day for 1 month tapered off to once daily within 6 months and then once a day for 6 months. Intervention group: DMS 0.1% 6 times a day for 1 month followed by FML 0.1% 4 times a day for two months tapered off to once daily within four months and then once a day for 6 months. STEP-II (Year 2): Control Group: Half the patients in each study arm will use FML 0.1% daily. Intervention Group: Half the patients in each study arm will discontinue steroids. Main study parameters/endpoints: Primary outcomes: Step-I: IOP elevation compared to baseline Step-II: Endothelial cell loss (ECL) compared to pre-surgical baseline Secondary outcomes are: - Rejection free graft survival. - Patient reported outcome measures. - Incremental cost-effectiveness ratios, including a short term trial-based economic evaluation (TBEE) and a life-long model-based economic evaluation (MBEE) - Structural outcomes including corneal, central macular and retinal nerve fibre layer thicknesses, and optic nerve head imaging.

NCT ID: NCT05636579 Recruiting - Clinical trials for Endothelial Dysfunction

Study to Assess Safety and Tolerability of Multiple Doses of EO2002

Start date: December 1, 2022
Phase: Phase 1
Study type: Interventional

The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil.

NCT ID: NCT05531760 Completed - Clinical trials for Pseudophakic Bullous Keratopathy

Predictive Factors of Graft Detachment Following Dmek

PDF DMEKDETACH
Start date: March 1, 2022
Phase:
Study type: Observational

The aim of this study was to identify the predictive factors of graft detachment after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. This retrospective study was conducted on patients aged 18 years, with Fuchs' dystrophy (FECD) or pseudophakic bullous keratopathy (PBK), who were scheduled for DMEK or triple-DMEK (combined phacoemulsification and DMEK surgery). Patients with a history of surgery other than cataract surgery were excluded. The study was conducted between 2014 and 2022 and follow-up was for 3 months. The characteristics of patients with and without graft detachment following surgery were compared using logistic regression.

NCT ID: NCT05436665 Recruiting - Clinical trials for Fuchs' Endothelial Dystrophy

The Belgian Endothelial Surgical Transplant of the Cornea

BESTCornea
Start date: August 10, 2022
Phase: N/A
Study type: Interventional

This study is designed as a randomised multicentric parallel group pragmatic trial of Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK) in corneal endothelial decompensation. the purpose is to compare the clinical and patient reported outcomes of both therapies across a broad range of indications.