Back to resultsIntraocular Pressure After Preserflo / Innfocus Microshunt Implantation vs Trabeculectomy (PAINT)
Primary Purpose
Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Preserflo / Innfocus Microshunt
Trabeculectomy
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma
Eligibility Criteria
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
Sites / Locations
- Medical University Innsbruck
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Microshunt
Trabeculectomy
Arm Description
Patients will be treated with Preserflo / Innfocus Microshunt (Santen Pharmaceutical Co., Ltd.).
Patients will be treated with trabeculectomy.
Outcomes
Primary Outcome Measures
Difference in intraocular pressure
The primary endpoint is the difference between intraocular pressure after microshunt implantation vs trabeculectomy.
Secondary Outcome Measures
Full Information
NCT ID
NCT04440527
First Posted
June 18, 2020
Last Updated
June 18, 2020
Sponsor
Medical University Innsbruck
1. Study Identification
Unique Protocol Identification Number
NCT04440527
Brief Title
Intraocular Pressure After Preserflo / Innfocus Microshunt Implantation vs Trabeculectomy
Acronym
PAINT
Official Title
Intraocular Pressure After Preserflo /Innfocus Microshunt vs Trabeculectomy: a Prospective, Randomised Control-trial (PAINT-Study)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 22, 2020 (Anticipated)
Primary Completion Date
July 22, 2022 (Anticipated)
Study Completion Date
July 22, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University Innsbruck
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Microshunt
Arm Type
Experimental
Arm Description
Patients will be treated with Preserflo / Innfocus Microshunt (Santen Pharmaceutical Co., Ltd.).
Arm Title
Trabeculectomy
Arm Type
Active Comparator
Arm Description
Patients will be treated with trabeculectomy.
Intervention Type
Device
Intervention Name(s)
Preserflo / Innfocus Microshunt
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Trabeculectomy
Intervention Description
Trabeculectomy is the most commonly performed surgical procedure and is considered the gold standard.
Primary Outcome Measure Information:
Title
Difference in intraocular pressure
Description
The primary endpoint is the difference between intraocular pressure after microshunt implantation vs trabeculectomy.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teresa Rauchegger, Dr.
Phone
+43 512 504 24184
Email
teresa.rauchegger@i-med.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Teuchner, Dr.
Phone
+43 512 504 24184
Email
barbara.teuchner@i-med.ac.at
Facility Information:
Facility Name
Medical University Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Intraocular Pressure After Preserflo / Innfocus Microshunt Implantation vs Trabeculectomy
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