Baerveldt Versus Paul Study
NCT07733453 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2026-08-03
Summary
The Baerveldt Versus Paul (BvP) Study is a Registry-based Randomised Controlled Trial, Comparing the Baerveldt Glaucoma Implant (BGI) and the Paul Glaucoma Implant (PGI). Participants will Include patients requiring aqueous shunt surgery for control of intraocular pressure and glaucoma.
The objective of this study is to compare the long-term safety and effectiveness of placement of a BGI and PGI for patients who are undergoing aqueous shunt implant surgery. Patients who qualify for the study are randomized to receive either a BGI or PGI aqueous shunt.
Conditions
Interventions
- DEVICE
-
Baerveldt Glaucoma Implant
Surgical insertion of an aqueous shunt for control of intraocular pressure and/or glaucoma
- DEVICE
-
Paul Glaucoma Implant
Surgical insertion of an aqueous shunt for control of intraocular pressure and/or glaucoma
Sponsors & Collaborators
-
University of Sydney
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-10-12
- Primary Completion
- 2033-04-30
- Completion
- 2033-04-30
Countries
- Australia
Study Locations
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