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Corneal Dystrophies, Hereditary clinical trials

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NCT ID: NCT05694598 Not yet recruiting - Clinical trials for Bietti Crystalline Dystrophy

Safety and Tolerability of VGR-R01 for Patients With Bietti Crystalline Dystrophy

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

A Multicenter, Open-Label, Non-Randomized, Uncontrolled Study of VGR-R01 in Patients with Bietti Crystalline Dystrophy.

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: NCT05399069 Recruiting - Clinical trials for Bietti Crystalline Dystrophy

Safety and Tolerability of VGR-R01 in Patients With Bietti Crystalline Dystrophy

Start date: September 15, 2022
Phase: Early Phase 1
Study type: Interventional

An Open-Label, Non-Randomized, Uncontrolled, Single-dose Pilot Study of VGR-R01 in Patients with Bietti Crystalline Dystrophy.

NCT ID: NCT05376176 Active, not recruiting - Clinical trials for Fuchs Endothelial Corneal Dystrophy

A Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD)

PHANTOM
Start date: May 19, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase IIa study to assess efficacy and safety of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing when compared to Placebo in subjects diagnosed with Fuchs Endothelial Corneal Dystrophy (FECD). This study will consist of a Screening Period of up to 15 days and an 18-month Double-Masked Treatment Period, including 9 individual visits to the study site.

NCT ID: NCT05279157 Completed - Keratoconus Clinical Trials

Autologous Adipose-Derived Adult Stem Cell Implantation for Corneal Diseases (ADASCs-CT-CD)

ADASCs-CT-CD
Start date: April 19, 2022
Phase: Phase 2
Study type: Interventional

Cellular therapy of the corneal stroma with implantation of mesenchymal stem cells derived from autologous adipose tissue with or without a carrier (scaffold) composed by decellularized human donor corneal stroma is used in patients with corneal diseases such as corneal dystrophies, and keratoconus. For this purpose, the study planned to assess the enhancement of visual acuity, pachymetric, and aberrometric parameters with implantation of autologous mesenchymal adipose tissue-derived adult stem cells (ADASCs) alone, 120 µm thickness of decellularized or recellularized laminas with ADASCs. Three groups will be included in the study: (1) Implantation of a single dose of ADASCs alone without scaffold. (2) Implantation of decellularized human corneal lamina without ADASCs. (3) Implantation of the recellularized human corneal lamina with ADASCs.

NCT ID: NCT05052554 Withdrawn - Corneal Diseases Clinical Trials

Study With QR-504a to Evaluate Safety, Tolerability & Corneal Endothelium Molecular Biomarker(s) in Subjects With FECD3

Fuchs Focus
Start date: August 10, 2021
Phase: Phase 1
Study type: Interventional

PQ-504a-001 (Fuchs Focus) is an open-label, single-dose, exploratory study to evaluate safety, tolerability, and corneal endothelium molecular biomarker(s) in subjects with Fuchs Endothelial Corneal Dystrophy with Trinucleotide Repeat Expansion in the TCF4 gene (FECD3).

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: NCT04722107 Recruiting - Clinical trials for Bietti's Crystalline Dystrophy

Safety Study of rAAV2/8-hCYP4V2 in Patients With Bietti's Crystalline Dystrophy (BCD)

Start date: April 21, 2021
Phase: Early Phase 1
Study type: Interventional

Primary Objectives: To evaluate the safety of rAAV2/8-hCYP4V2 gene replacement therapy drug administered as a single subretinal injection in patients with Bietti's Crystalline Dystrophy (BCD). Secondary Objectives: To preliminarily explore the clinical effectiveness of rAAV2/8-hCYP4V2 gene replacement therapy drugs.

NCT ID: NCT04667572 Active, not recruiting - Keratoconus Clinical Trials

Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

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

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions

NCT ID: NCT04642729 Enrolling by invitation - Clinical trials for Macular Corneal Dystrophy

Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex Smile Surgery

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

The aim of the study is to examine the effect of fresh corneal lenticule implantation as allogenic graft taken from myopic patients to implanted in patients with macular corneal dystrophy using Visumax Femtosecond Laser Smile module surgery.