Vienna Preserflo Cohort Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
During the inclusion period two slightly different surgical approaches have been used. At the beginning of the surgery, the conjunctiva is opened and the Tenon capsule is getting dissected from the sclera. In the first group of patients (group 1) we made a fornix based conjunctival opening, prepared a 1mm wide and long scleral pocket in 3mm distance from limbus and placed the PMS in the anterior chamber via a 25G needle track. In the second group (group 2) the conjunctival opening was 3.5 mm from the limbus, the scleral pocket was prepared at 3.5 mm distance from the limbus and a 27G needle was used. The outcomes of these two groups will be compared.
Study Design
Outcome Measures
Primary Outcome Measures
- IOP [one year]
IOP in mmHg
- Full success [one year]
IOP below 21 and IOP reduction of at least 20% from baseline without medication
- Qualified success [one year]
IOP below 21 and IOP reduction of at least 20% from baseline with or without medication
- Complications [one year]
Number of complications per eye
Secondary Outcome Measures
- Re-intervention rate rate [one year]
Proportion of eyes requiring either needling revision of filtering bleb revision or any other glaucoma surgery
- Medication rate [one year]
Number of patients who needed again eye pressure lowering medication
- Average medication [one year]
Average number of different eye pressure lowering medication
- OCT - shunt entry [one year]
Shunt position in chamber angle as determined by anterior segment OCT
- OCT - shunt clearance [one year]
Shunt-cornea angle as determined by anterior segment OCT
- OCT - shunt length [one year]
Shunt length in the anterior chamber as determined by anterior segment OCT
- Corneal endothelial cell count [one year]
Corneal endothelial cell count in specular microscopy of corneal endothelium
Eligibility Criteria
Criteria
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:
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Unwilling or unable to give informed consent.
-
Pregnancy or lactation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Insitute of Ophthalmology and Optometry, Medical University of Vienna | Vienna | Austria | 1090 |
Sponsors and Collaborators
- Medical University of Vienna
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1142_2020