Vienna Preserflo Cohort Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04541524
Study type	Observational
Source	Medical University of Vienna
Contact	Clemens Vass, Univ.Prof
Phone	0043140400
Email	clemens.vass@meduniwien.ac.at
Status	Recruiting
Phase
Start date	June 5, 2020
Completion date	November 30, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06000865` - Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE	N/A
Recruiting	`NCT06278597` - Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device	N/A
Active, not recruiting	`NCT04271709` - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)	N/A
Recruiting	`NCT03274024` - The Asia Primary Tube Versus Trab (TVT) Study	N/A
Completed	`NCT04552964` - Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma	N/A
Recruiting	`NCT01957267` - Functional and Structural Imaging for Glaucoma
Active, not recruiting	`NCT04624698` - iStent Inject New Enrollment Post-Approval Study	N/A
Completed	`NCT04020705` - The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma	N/A
Completed	`NCT03150160` - Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma	Phase 4
Not yet recruiting	`NCT05581498` - Glaucoma Exercise as Medicine Study (GEMS).	N/A
Recruiting	`NCT02921568` - Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes	N/A
Active, not recruiting	`NCT02901730` - Clinical Study of LPI With Different Laser Wavelengths	N/A
Completed	`NCT02955849` - A Trial of China Laser and Surgery Study Glaucoma in Rural China	Early Phase 1
Recruiting	`NCT02471105` - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml	Phase 4
Recruiting	`NCT02554214` - Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device	N/A
Active, not recruiting	`NCT02390284` - Stop Retinal Ganglion Cell Dysfunction Study	Phase 3
Completed	`NCT02390245` - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study	N/A
Completed	`NCT02520674` - Glaucoma Screening With Smartphone Ophthalmology	N/A
Completed	`NCT02628223` - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma	N/A
Completed	`NCT02653963` - Triamcinolone for Ahmed Glaucoma Valve	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.