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NCT04440527 Clinical Trial

Intraocular Pressure After Preserflo / Innfocus Microshunt Implantation vs Trabeculectomy

Primary Open Angle Glaucoma Clinical Trial

— PAINT  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04440527
Other study ID # PAINT-Study
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 22, 2020
Est. completion date July 22, 2024

Study information
Verified date June 2020
Source Medical University Innsbruck
Contact Teresa Rauchegger, Dr.
Phone +43 512 504 24184
Email teresa.rauchegger@i-med.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 70
Est. completion date July 22, 2024
Est. primary completion date July 22, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Austria Medical University Innsbruck Innsbruck Tyrol

Sponsors (1)
Lead Sponsor Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference in intraocular pressure The primary endpoint is the difference between intraocular pressure after microshunt implantation vs trabeculectomy. 1 year
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