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Fuchs' Endothelial Dystrophy clinical trials

View clinical trials related to Fuchs' Endothelial Dystrophy.

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NCT ID: NCT04175938 Recruiting - Clinical trials for Fuchs' Endothelial Corneal Dystrophy

Assessment of Corneal Endothelial Function Following Hypoxic Stress

Start date: July 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the difference in the cornea's response to contact lens placement between healthy and unhealthy eyes. The amount of corneal swelling (corneal thickness) between normal and FECD patients before and after a stress test will be measured and compared.

NCT ID: NCT04140422 Completed - Clinical trials for Fuchs' Endothelial Dystrophy

Eye Drops for Early Morning-Associated Corneal Swelling of the Cornea

EDEMAS
Start date: October 24, 2019
Phase: N/A
Study type: Interventional

This study evaluates the efficacy of hyperosmolar eye drops on early morning edema of the cornea in patients with Fuchs' endothelial corneal dystrophy (FECD). Each participant will receive hyperosmolar eye drops in one eye and lubricating eye drops in the fellow eye.

NCT ID: NCT04072029 Completed - Cataract Clinical Trials

Risk Assessment for Progression to DMEK Following Cataract Surgery in Fuchs Endothelial Corneal Dystrophy

Start date: July 1, 2017
Phase:
Study type: Observational

Justification. Fuchs' corneal endothelial dystrophy (FECD) is one of the main causes of corneal transplantation. In many cases, the corneal decompensation derived from this dystrophy is triggered as a consequence of cataract surgery, so the dilemma of facing isolated cataract surgery or combined with endothelial keratoplasty is often raised. Objective. The present study aims to evaluate and select the most important predictive factors for corneal decompensation after cataract surgery in patients with FECD. Method. Prospective observational study of the preoperative and intraoperative variables presumably associated with postoperative corneal edema requiring Descemet stripping endothelial keratoplasty (DMEK). Consecutive candidates for cataract surgery with FECD will be selected and anterior segment imaging will be performed, along with a complete ophthalmological examination. Clinical, pachymetric, tmographic, densitometric, specular microscopy, and intraoperative variables will be registered.

NCT ID: NCT04057053 Completed - Cataract Clinical Trials

Netarsudil Use After Descemetorhexis Without Endothelial Keratoplasty

Start date: October 2, 2018
Phase: Early Phase 1
Study type: Interventional

Primary aim of the study is to determine whether a rho kinase inhibitor, Netarsudil, can speed corneal clearance after DWEK. Secondary aim of the study is to investigate whether patient factors, such as baseline age, pachymetry, or endothelial cell count influence response to Netarsudil.

NCT ID: NCT04051463 Completed - Clinical trials for Fuchs Endothelial Dystrophy

Rhopressa for Corneal Edema Associated With Fuchs Dystrophy

Start date: August 5, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The study objective is to determine whether use of Rhopressa improves the ability of corneal endothelial cells to maintain appropriate corneal hydration in patients with Fuchs endothelial corneal dystrophy (FECD), which could help delay or prevent the need for a corneal transplant.

NCT ID: NCT04018417 Withdrawn - Clinical trials for Fuchs' Endothelial Dystrophy

Evaluation of Amphotericin B in Optisol-GS for Prevention of Post-Keratoplasty Fungal Infections.

Start date: July 3, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

With the increasing popularity of endothelial keratoplasty, a coincident increase in the rate of fungal infections post-keratoplasty has been seen in the United States. In this study, the eye bank will harvest pairs of donor corneas and randomize one cornea from each pair to be stored in Optisol-GS per Eye Bank Association of America guidelines. The eye bank will add amphotericin B 0.255 μg/mL (antifungal) to the storage solution for the mate cornea. The study donor corneas will be assigned to participants who are scheduled to undergo Descemet membrane endothelial keratoplasty. The surgeons, participants, and evaluators will remain masked regarding the donor cornea storage solution assignment. The participants will be followed for 6 months.

NCT ID: NCT03974230 Completed - Clinical trials for Fuchs Endothelial Corneal Dystrophy

Analysis of the Genotype/Phenotype Relationship in the Fuchs' Corneal Endothelial Dystrophy in France.

F3S
Start date: August 1, 2019
Phase:
Study type: Observational

The pathophysiology of the most common corneal endothelial dystrophies (Fuchs' Corneal Endothelial Dystrophy (FECD)) is beginning to be dismembered. One of the most common genetic anomalies is a triplet repetition in one of the introns of the Transcription Factor 4 (TCF4) gene located on chromosome 18. However, the number of repetitions varies greatly from one patient to another.

NCT ID: NCT03971357 Terminated - Clinical trials for Fuchs' Endothelial Dystrophy

Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration

Start date: July 22, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Subjects with Fuchs dystrophy will be randomized to use either netarsudil or placebo eye drops to determine if the use of netarsudil accelerates migration of host peripheral corneal endothelial cells to restore the central endothelial cell layer.

NCT ID: NCT03813056 Recruiting - Clinical trials for Fuchs Endothelial Dystrophy

Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy

Start date: March 25, 2019
Phase: Phase 2
Study type: Interventional

Recently, published literature has reported that performing a descemetorhexis in combination with topical Rho kinase (ROCK) inhibitor therapy was successful in clearing edematous corneas in patients with Fuchs Endothelial Corneal Dystrophy. Ripasudil hydrochloride hydrate( Glanatec ophthalmic solution 0.4%), a potent ROCK inhibitor, has been approved in Japan since 2014 for ocular use in the treatment of glaucoma. Ripasudil acts as an IOP-lowering drug by affecting aqueous outflow through the trabecular meshwork and Schlemm's canal. The goal of this study is to test the potential benefits of Ripasudil therapy administered after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. We believe that performing a standard DMEK surgery in combination with Ripasudil treatment in patients with Fuchs Endothelial Corneal Dystrophy could accelerate endothelial cell healing and clear edematous corneas faster, with less post-operative complications.

NCT ID: NCT03763721 Completed - Vision Disorders Clinical Trials

The ADVISE Study: Advanced Visualization In Corneal Surgery Evaluation

ADVISE
Start date: November 13, 2018
Phase: N/A
Study type: Interventional

Rationale: Intra-operative optical coherence tomography (iOCT) is a new technology that incorporates advanced imaging techniques in the ophthalmic operating theatre. This allows surgeons to visualize tissues in a way previously impossible We conceptualized an iOCT-guided surgical protocol for the treatment of endothelial cell dysfunction, that refrains from the current practice of over-pressurizing the eye at the end of surgery. Objective: The aim of this study is to assess the clinical value of intraoperative OCT (iOCT) for Descemet Membrane Endothelial Keratoplasty (DMEK) by comparing an iOCT-optimized surgical protocol with current practice, where the eye is over-pressurized for a set period of time, in terms of surgical efficiency, clinical outcomes, and adverse events. Study design: International multicentre non-inferiority randomized clinical trial Study population: Patients scheduled for posterior lamellar corneal surgery for endothelial cell dysfunction above the age of 18 years. Intervention: Both groups will undergo Descemet Membrane Endothelial Keratoplasty. Patients will be randomized for either the iOCT optimized surgical protocol or current standard surgical protocol using 8 minutes of overpressure to facilitate graft adherence. Both groups will be evaluated with iOCT at the end of surgery. Main study parameters/endpoints: The main study parameter is the rate of adverse events (particularly graft dislocations). Secondary parameters/endpoints are surgical time, the recovery of visual acuity and endothelial graft quality at 3 and 6 months follow-up, and a detailed evaluation of the extent/duration of surgical tissue manipulations. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The use of iOCT during surgery does not entail additional risk to the patient. Participants to this study will adhere to the standard of care after corneal transplant surgery. In addition, they will receive study specific measurements and questionnaires. The additional measurements and questionnaires will be combined with regular follow up moments.