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.
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
70
The PMS is 8.5 mm long has an outer diameter of 350 μm and a lumen diameter of 70 μm. It has a fin sized 1.1 mm located 4.5 mm distally from the internal tip of the device and it consists of poly(styrene-b-isobutylene-b-styrene) SIBS. The device was implanted 1 year prior to the present study via an ab externo approach. At the beginning of the surgery, the conjunctiva was opened. 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. PMS guides aqueous humor from the anterior chamber to the subconjunctival space. The forming filtering bleb absorbs aqueous humor which leads to IOP reduction.
Insitute of Ophthalmology and Optometry, Medical University of Vienna
Vienna, Austria
RECRUITINGIOP
IOP in mmHg
Time frame: one year
Full success
IOP below 21 and IOP reduction of at least 20% from baseline without medication
Time frame: one year
Qualified success
IOP below 21 and IOP reduction of at least 20% from baseline with or without medication
Time frame: one year
Complications
Number of complications per eye
Time frame: one year
Re-intervention rate rate
Proportion of eyes requiring either needling revision of filtering bleb revision or any other glaucoma surgery
Time frame: one year
Medication rate
Number of patients who needed again eye pressure lowering medication
Time frame: one year
Average medication
Average number of different eye pressure lowering medication
Time frame: one year
OCT - shunt entry
Shunt position in chamber angle as determined by anterior segment OCT
Time frame: one year
OCT - shunt clearance
Shunt-cornea angle as determined by anterior segment OCT
Time frame: one year
OCT - shunt length
Shunt length in the anterior chamber as determined by anterior segment OCT
Time frame: one year
Corneal endothelial cell count
Corneal endothelial cell count in specular microscopy of corneal endothelium
Time frame: one year
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