Vienna Preserflo Cohort Study

• Conditions: Glaucoma Surgery; Efficacy, Self; Glaucoma; Safety Issues; Post-Op Complication

• Registration Number: NCT04541524
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2020-06-05
• Study First Submitted: 2020-07-17
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-01
• Last Update Submitted: 2020-09-01
• Study First Posted: 2020-09-09
• Last Update Posted: 2020-09-09
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Medication rate	one year	Number of patients who needed again eye pressure lowering medication
Corneal endothelial cell count	one year	Corneal endothelial cell count in specular microscopy of corneal endothelium
OCT - shunt length	one year	Shunt length in the anterior chamber as determined by anterior segment OCT
OCT - shunt entry	one year	Shunt position in chamber angle as determined by anterior segment OCT
Re-intervention rate rate	one year	Proportion of eyes requiring either needling revision of filtering bleb revision or any other glaucoma surgery
Average medication	one year	Average number of different eye pressure lowering medication
OCT - shunt clearance	one year	Shunt-cornea angle as determined by anterior segment OCT

Trial Locations

Locations (1)

Insitute of Ophthalmology and Optometry, Medical University of Vienna; 🇦🇹 Vienna, Austria