Baerveldt Versus Paul Study

Sponsor
University of Sydney
Study ID
NCT07733453
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Baerveldt Glaucoma Implant — DEVICE
    Surgical insertion of an aqueous shunt for control of intraocular pressure and/or glaucoma
  • Paul Glaucoma Implant — DEVICE
    Surgical insertion of an aqueous shunt for control of intraocular pressure and/or glaucoma

Study Details

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.

Key Dates

First listed
Jul 29, 2026
Start date
Oct 12, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2033
Completion
Apr 30, 2033

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Baerveldt Glaucoma Implant
    Patients randomised to this arm will undergo insertion of a Baerveldt Glaucoma Implant.
  • Active Comparator: Paul Glaucoma Implant
    Patients randomised to this arm will undergo insertion of a Paul Glaucoma Implant.

Primary Outcome Measure

Surgical Failure [ Time Frame: From enrollment until the end of follow up at 5 years postoperative. ]

Central Contacts

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