Glaucoma Clinical Trial
Official title:
Vienna Preserflo Microshunt Cohort Study
NCT number | NCT04541524 |
Other study ID # | 1142_2020 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 5, 2020 |
Est. completion date | November 30, 2020 |
The Vienna Preserflo Microshunt Cohort Study is an observational study with a prospective postoperative examination in all glaucoma patients who had received a Preserflo Microshunt (PMS) as standalone procedure or in combination with cataract extraction in the time period between January and November 2019 at the Department of Ophthalmology, Medical University of Vienna. It is estimated that approximately 70 patients will be included of this cohort. The cohort will be invited for a prospective postoperative examination after 12 (±5) months of follow up. This examination shall comprise best corrected visual acuity, visual field test, intraocular pressure (IOP) measurement, slit lamp examination, fundus examination (optic disc and retina), gonioscopic assessment of PMS position, anterior segment optical coherence tomography (OCT) (shunt position, anterior chamber angle assessment, limbus shape analysis), corneal pachymetry, specular microscopy of corneal endothelial cells. Additionally, retrospective information concerning IOP, medication and visual fields of all patients will be collected from the Department of Ophthalmology as well as from the referring ophthalmologists where possible. Additionally, we will perform a comparison between two groups to compare differences in outcome measures.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | November 30, 2020 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 95 Years |
Eligibility |
Inclusion Criteria: - Glaucoma patients who received a PMS in the time period between January and November 2019 at the Department of Ophthalmology, Medical University of Vienna, Austria, will be invited Exclusion Criteria: - Unwilling or unable to give informed consent. - Pregnancy or lactation |
Country | Name | City | State |
---|---|---|---|
Austria | Insitute of Ophthalmology and Optometry, Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IOP | IOP in mmHg | one year | |
Primary | Full success | IOP below 21 and IOP reduction of at least 20% from baseline without medication | one year | |
Primary | Qualified success | IOP below 21 and IOP reduction of at least 20% from baseline with or without medication | one year | |
Primary | Complications | Number of complications per eye | one year | |
Secondary | Re-intervention rate rate | Proportion of eyes requiring either needling revision of filtering bleb revision or any other glaucoma surgery | one year | |
Secondary | Medication rate | Number of patients who needed again eye pressure lowering medication | one year | |
Secondary | Average medication | Average number of different eye pressure lowering medication | one year | |
Secondary | OCT - shunt entry | Shunt position in chamber angle as determined by anterior segment OCT | one year | |
Secondary | OCT - shunt clearance | Shunt-cornea angle as determined by anterior segment OCT | one year | |
Secondary | OCT - shunt length | Shunt length in the anterior chamber as determined by anterior segment OCT | one year | |
Secondary | Corneal endothelial cell count | Corneal endothelial cell count in specular microscopy of corneal endothelium | one year |
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