Status:
RECRUITING
Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy
Lead Sponsor:
Marian Macsai, MD
Conditions:
Fuchs' Endothelial Dystrophy
Eligibility:
All Genders
18-91 years
Phase:
PHASE4
Brief Summary
In brief, the objective of this study is to investigate whether the drug Glanatec ® which is approved in Japan for glaucoma and ocular hypertension, can be used in patients with Fuchs endothelial dyst...
Eligibility Criteria
Inclusion
- • Ability to understand read and sign the informed consent form.
- Age between 30 and \<91 years
- Ability to understand and follow instructions and study procedures
- Willingness to comply with all study procedures and be available for the duration of the study
- Ability to apply eye drop medication and willing to adhere to study medication regimen
- Diagnosed with Fuchs dystrophy (clinically and on confocal microscopy) by the study investigator.
- Pseudophakic FED with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens.
- Fuchs dystrophy grades 2-4 on the Krachmer grading scale
- Presence of central guttae deemed by the investigator to be the chief cause of visual symptoms, rather than cataract or corneal stromal edema
- Clear peripheral cornea with an endothelial cell count \>1000 cells/mm2 on specular microscopy
- Best corrected visual acuity in the study eye is 20/40 or worse at study enrollment
- The patient is dissatisfied with current vision
- The patient is otherwise to be offered a corneal graft
- For females with reproductive potential, willingness to use highly effective contraception (e.g., hormonal contraception, barrier contraception, intrauterine device, or abstinence).
- Indication for surgery may include cataract extraction and posterior chamber intraocular lens implantation
Exclusion
- • Uncontrolled glaucoma (IOP \>25 mmHg)
- Presence of secondary corneal pathology such as infective or autoimmune keratitis
- Advanced corneal stromal edema defined as the presence of haze, bullae, or DM folds on slit-lamp biomicroscopy
- History of herpes simplex virus or cytomegalovirus keratitis
- Prior endothelial keratoplasty
- Aphakic in study eye.
- Allergy to any component of the Ripasudil hydrochloride hydrate 0.4% that will be used in the course of the study
- For women of child-bearing potential: Pregnant or lactating, or planning to become pregnant within the next 6 months.
- Any other ocular condition that, in the opinion of the investigator, may preclude the subject from study participation.
Key Trial Info
Start Date :
December 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03249337
Start Date
December 6 2017
End Date
December 1 2021
Last Update
August 11 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
NorthShore University HealthSystem
Glenview, Illinois, United States, 60026