Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma
Conditions
Brief summary
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.
Detailed description
The study is a prospective, randomized, monocentric, part blinded, controlled non-inferiority study of glaucoma patients.
Interventions
DEVICEPreserflo / Innfocus Microshunt
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.
OTHERTrabeculectomy
Trabeculectomy is the most commonly performed surgical procedure and is considered the gold standard.
Sponsors
Medical University Innsbruck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in intraocular pressure | 1 year | The primary endpoint is the difference between intraocular pressure after microshunt implantation vs trabeculectomy. |
Countries
Austria
Contacts
Primary ContactTeresa Rauchegger, Dr.
Backup ContactBarbara Teuchner, Dr.
Outcome results
None listed