Status:

UNKNOWN

Intraocular Pressure After Preserflo / Innfocus Microshunt Implantation vs Trabeculectomy

Lead Sponsor:

Medical University Innsbruck

Conditions:

Primary Open Angle Glaucoma

Pseudoexfoliation Glaucoma

Eligibility:

All Genders

18+ years

Phase:

NA

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 intraoc...

Detailed Description

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 22 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 22 2024

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT04440527

Start Date

July 22 2020

End Date

July 22 2024

Last Update

June 19 2020

Active Locations (1)

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Medical University Innsbruck

Innsbruck, Tyrol, Austria, 6020