Trials / Unknown
UnknownNCT04440527
Intraocular Pressure After Preserflo / Innfocus Microshunt Implantation vs Trabeculectomy
Intraocular Pressure After Preserflo /Innfocus Microshunt vs Trabeculectomy: a Prospective, Randomised Control-trial (PAINT-Study)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- Medical University Innsbruck · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-07-22
- Primary completion
- 2022-07-22
- Completion
- 2024-07-22
- First posted
- 2020-06-19
- Last updated
- 2020-06-19
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT04440527. Inclusion in this directory is not an endorsement.