Intraocular Pressure After Preserflo / Innfocus Microshunt Implantation vs Trabeculectomy

Medical University Innsbruck70 enrolled

Overview

The aim of this project is to compare trabeculectomy with Preserflo / Innfocus Microshunt in patients with Primary Angle Open Glaucoma and Pseudoexfoliation Glaucoma regarding the reduction of intraocular pressure.

The study is a prospective, randomized, monocentric, part blinded, controlled non-inferiority study of glaucoma patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Primary Open Angle Glaucoma Pseudoexfoliation Glaucoma

Interventions

Preserflo / Innfocus MicroshuntDEVICE

The Microshunt features an 8.5-mm tube with an outer diameter of 350 µm and a 70-µm diameter lumen. Implantation creates a subconjunctival bleb and lowers intraocular pressure by increasing aqueous humor outflow.

TrabeculectomyOTHER

Trabeculectomy is the most commonly performed surgical procedure and is considered the gold standard.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Primary open angle glaucoma or pseudoexfoliation glaucoma * medically uncontrollable intraocular pressure or intolerance of topical therapy * negative urine/serum pregnancy test of women in childbearing age * signed and dated informed consent Exclusion Criteria: * previous incisional glaucoma procedure on affected eye * pregnancy, nursing period * Patients in military service, training periods and civil service * Participation in another clinical trail * pre-existing ocular pathologies: high myopia (refraction ≥8.00 D), thin conjunctiva

Locations (1)

Medical University Innsbruck

Innsbruck, Tyrol, Austria

Outcomes

Primary Outcomes

Difference in intraocular pressure

The primary endpoint is the difference between intraocular pressure after microshunt implantation vs trabeculectomy.

Time frame: 1 year

Central Contacts

Teresa Rauchegger, Dr.

CONTACT

+43 512 504 24184 teresa.rauchegger@i-med.ac.at

Barbara Teuchner, Dr.

CONTACT

+43 512 504 24184 barbara.teuchner@i-med.ac.at

Data from ClinicalTrials.gov

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