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Fuchs Dystrophy clinical trials

View clinical trials related to Fuchs Dystrophy.

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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: 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: NCT05275972 Recruiting - Clinical trials for Fuchs' Endothelial Dystrophy

Descemet Endothelial Thickness Comparison Trial II

DETECT II
Start date: January 23, 2023
Phase: Phase 3
Study type: Interventional

Descemet Endothelial Thickness Comparison Trial (DETECT) II is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 60 patients with Fuchs endothelial dystrophy to DMEK versus Descemet Stripping Only (DSO) with adjunctive Ripasudil.

NCT ID: NCT04894110 Active, not recruiting - Clinical trials for Endothelial Dysfunction

Study of Safety and Tolerability of EO2002 in the Treatment of Corneal Edema

Start date: June 22, 2021
Phase: Phase 1
Study type: Interventional

Corneal edema is the most common indication for corneal transplantation, accounting for approximately 70% of penetrating keratoplasty (PK), and 100% of endothelial keratoplasty (EK) procedures annually. There is currently no disease-modifying treatment for corneal edema. Topical treatments like hypertonic saline are not effective on a long-term basis. For those with advanced disease, where edema and vision loss are not controlled by topical treatment, the only option is a corneal transplant. A potential approach to avoidance of the risks of corneal transplantation is to inject cultured human corneal endothelial cells (HCECs) into the anterior chamber of the eye. This approach may avoid surgery by re-populating the inner most aspect of the cornea with functioning endothelial cells. Emmecell has developed a treatment based on technology integrating biocompatible magnetic nanoparticles with cultured HCECs to treat corneal edema in a minimally invasive way. The primary objective of this phase 1, prospective, multi-center, open-label, dose-escalation study is to evaluate the safety and tolerability of 3 doses of EO2002 with and without endothelial brushing (EB) or Descemet Stripping (DS) in eyes with corneal edema secondary to corneal endothelial dysfunction that qualify for surgery involving full-thickness corneal transplantation or EK.

NCT ID: NCT04676737 Completed - Clinical trials for Fuchs' Endothelial Dystrophy

TTHX1114(NM141) in Combination With DWEK/DSO

Start date: February 1, 2021
Phase: Phase 2
Study type: Interventional

Open label, single-treatment, with a concurrent non-treatment control

NCT ID: NCT04564378 Active, not recruiting - Fuchs Dystrophy Clinical Trials

Association Between Fuchs' Endothelial Corneal Dystrophy Severity and Estrogen Exposure

Start date: January 17, 2018
Phase:
Study type: Observational

This study is being done to discover if there is a link between estrogen exposure and the severity of Fuchs Endothelial Corneal Disease. We are trying to understand if the decrease in estrogen levels in post-menopausal women may be a reason why FECD is seen more often in women than men.

NCT ID: NCT04527523 Terminated - Clinical trials for Cystoid Macular Edema

Descemet Membrane Endothelial Keratoplasty vs. Descemet's Stripping With Endothelial Keratoplasty vs. Descemet Stripping Only

Start date: November 21, 2020
Phase:
Study type: Observational

This study aims to evaluate and compare incidence of post-operative cystoid macular edema (CME) after Descemet Membrane Endothelial Keratoplasty (DMEK), Descemet's Stripping Automated endothelial Keratoplasty (DSEK) and Descemet Stripping Only (DSO).

NCT ID: NCT04258787 Recruiting - Fuchs Dystrophy Clinical Trials

OCT in Fuchs' Dystrophy

Start date: June 26, 2020
Phase:
Study type: Observational

This is an observational study using optical coherence tomography (OCT) technology to quantify corneal edema in Fuchs' endothelial dystrophy and predict refractive shift from resolving corneal edema after surgical treatments.

NCT ID: NCT04191629 Recruiting - Clinical trials for Fuchs' Endothelial Dystrophy

Phase 1 Study to Evaluate the Safety and Tolerability of EO1404 in the Treatment of Corneal Edema

Start date: May 4, 2016
Phase: Phase 1
Study type: Interventional

Single center, phase 1 study to evaluate the safety and tolerability of EO1404 in subjects with corneal edema secondary to pseudophakic bullous keratopathy or Fuch's endothelial dystrophy.

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.