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Intraocular Pressure After Preserflo / Innfocus Microshunt Implantation vs Trabeculectomy

NCT04440527 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-06-19

No results posted yet for this study

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.

Conditions

  • Primary Open Angle Glaucoma
  • Pseudoexfoliation Glaucoma

Interventions

DEVICE

Preserflo / 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.

OTHER

Trabeculectomy

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

Sponsors & Collaborators

  • Medical University Innsbruck

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-22
Primary Completion
2022-07-22
Completion
2024-07-22

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04440527 on ClinicalTrials.gov