Vienna Preserflo Cohort Study

September 1, 2020 updated by: Clemens Vass, Medical University of Vienna

Vienna Preserflo Microshunt Cohort Study

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.

Study Overview

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 Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Vienna, Austria, 1090
        • Recruiting
        • Insitute of Ophthalmology and Optometry, Medical University of Vienna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 93 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP
Time Frame: one year
IOP in mmHg
one year
Full success
Time Frame: one year
IOP below 21 and IOP reduction of at least 20% from baseline without medication
one year
Qualified success
Time Frame: one year
IOP below 21 and IOP reduction of at least 20% from baseline with or without medication
one year
Complications
Time Frame: one year
Number of complications per eye
one year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2020

Primary Completion (Anticipated)

November 30, 2020

Study Completion (Anticipated)

November 30, 2020

Study Registration Dates

First Submitted

July 17, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 1142_2020

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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