Intraocular Pressure After Preserflo / Innfocus Microshunt Implantation vs Trabeculectomy

Not Applicable

• Conditions: Primary Open Angle Glaucoma; Pseudoexfoliation Glaucoma
• Interventions: Device: Preserflo / Innfocus Microshunt; Other: Trabeculectomy

• Registration Number: NCT04440527
• Lead Sponsor: Medical University Innsbruck

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.

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-18
• Last Update Submitted: 2020-06-18
• Study First Posted: 2020-06-19
• Last Update Posted: 2020-06-19
• Study Start: 2020-07-22
• Primary Completion: 2022-07-22
• Study Completion: 2024-07-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microshunt	Preserflo / Innfocus Microshunt	Patients will be treated with Preserflo / Innfocus Microshunt (Santen Pharmaceutical Co., Ltd.).
Trabeculectomy	Trabeculectomy	Patients will be treated with trabeculectomy.

Primary Outcome Measures

Name	Time	Method
Difference in intraocular pressure	1 year	The primary endpoint is the difference between intraocular pressure after microshunt implantation vs trabeculectomy.

Trial Locations

Locations (1)

Medical University Innsbruck; 🇦🇹 Innsbruck, Tyrol, Austria