Intraocular Pressure After Preserflo / Innfocus Microshunt Implantation vs Trabeculectomy (PAINT)

June 18, 2020 updated by: Medical University Innsbruck

Intraocular Pressure After Preserflo /Innfocus Microshunt vs Trabeculectomy: a Prospective, Randomised Control-trial (PAINT-Study)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Medical University Innsbruck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microshunt
Patients will be treated with Preserflo / Innfocus Microshunt (Santen Pharmaceutical Co., Ltd.).
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.
Active Comparator: Trabeculectomy
Patients will be treated with trabeculectomy.
Other: Trabeculectomy
Trabeculectomy is the most commonly performed surgical procedure and is considered the gold standard.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in intraocular pressure
Time Frame: 1 year
The primary endpoint is the difference between intraocular pressure after microshunt implantation vs trabeculectomy.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 22, 2020

Primary Completion (Anticipated)

July 22, 2022

Study Completion (Anticipated)

July 22, 2024

Study Registration Dates

First Submitted

June 18, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

June 19, 2020

Last Update Submitted That Met QC Criteria

June 18, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAINT-Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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