Clinical trial NCT04541524: Vienna Preserflo Cohort Study
Official title: Vienna Preserflo Microshunt Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Glaucoma Surgery
Post-Op Complication
Efficacy, Self
Safety Issues
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glaucoma patients who received a PMS as stndalone procedure or in combination with a cataract surgery in the time period between January and November 2019 at the Department of Ophthalmology, Medical University of Vienna, Austria, will be invited

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.

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.

Eligibility 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:

* Unwilling or unable to give informed consent.
* Pregnancy or lactation

Primary outcomes:
measure: IOP
timeFrame: one year
measure: Full success
timeFrame: one year
measure: Qualified success
timeFrame: one year
measure: Complications
timeFrame: one year
Secondary outcomes:
measure: Re-intervention rate rate
timeFrame: one year
measure: Medication rate
timeFrame: one year
measure: Average medication
timeFrame: one year
measure: OCT - shunt entry
timeFrame: one year
measure: OCT - shunt clearance
timeFrame: one year
measure: OCT - shunt length
timeFrame: one year
measure: Corneal endothelial cell count
timeFrame: one year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Insitute of Ophthalmology and Optometry, Medical University of Vienna
Study officials:
References: