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NOT YET RECRUITING
NCT07733453
PHASE4

Baerveldt Versus Paul Study

Sponsor: University of Sydney

View on ClinicalTrials.gov

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.

Official title: The Baerveldt Versus Paul (BvP) Study: a Registry-based Randomised Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-10-12

Completion Date

2033-04

Last Updated

2026-08-03

Healthy Volunteers

Yes

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

Locations (4)

Sydney Eye Hospital

Sydney, New South Wales, Australia

Westmead Hospital

Sydney, New South Wales, Australia

Liverpool Hospital

Sydney, New South Wales, Australia

Royal Victorian Eye and Ear Hospital

Melbourne, Victoria, Australia