- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04541524
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
Status
Unknown
Intervention / Treatment
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
- Name: Clemens Vass, Univ.Prof
- Phone Number: 79400 0043140400
- Email: clemens.vass@meduniwien.ac.at
Study Locations
-
-
-
Vienna, Austria, 1090
- Recruiting
- Insitute of Ophthalmology and Optometry, Medical University of Vienna
-
Contact:
- Clemens Vass, Prof
- Phone Number: 40400 - 79400
- Email: clemens.vass@meduniwien.ac.at
-
-
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.
Sponsor
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
Additional Relevant MeSH Terms
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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