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

NCT07733453 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: BvP Study
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief 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

Glaucoma

Keywords

aqueous shunt surgery; glaucoma drainage device; glaucoma filtration surgery; Baerveldt Glaucoma Implant; Paul Glaucoma Implant

Outcome Measures

Primary Outcomes (1)

• Surgical Failure

  Failure in the BvP Study is defined by following criteria: * IOP \> 21 mmHg or \< 6 mmHg on 2 consecutive study visits at visits \> 3 months. * IOP not reduced by 20% (or more) below baseline on 2 consecutive study visits at visits \> 3 months. * Additional glaucoma surgery * Loss of light perception vision * Removal of implant for any reason

  From enrollment until the end of follow up at 5 years postoperative.

Secondary Outcomes (5)

• Intraocular Pressure

  From enrollment until the end of follow up at 5 years postoperative.

• Number of glaucoma medications

  From enrollment until the end of follow up at 5 years postoperative.

• Visual acuity

  From enrollment until the end of follow up at 5 years postoperative.

• Visual field outcomes

  From enrollment until the end of follow up at 5 years postoperative.

• Safety Outcomes

  From enrollment until the end of follow up at 5 years postoperative.

Study Arms (2)

Baerveldt Glaucoma Implant

ACTIVE COMPARATOR

Patients randomised to this arm will undergo insertion of a Baerveldt Glaucoma Implant.

Device: Baerveldt Glaucoma Implant

Paul Glaucoma Implant

ACTIVE COMPARATOR

Patients randomised to this arm will undergo insertion of a Paul Glaucoma Implant.

Device: Paul Glaucoma Implant

Interventions

Baerveldt Glaucoma Implant DEVICE

Surgical insertion of an aqueous shunt for control of intraocular pressure and/or glaucoma

Baerveldt Glaucoma Implant

Paul Glaucoma Implant DEVICE

Surgical insertion of an aqueous shunt for control of intraocular pressure and/or glaucoma

Paul Glaucoma Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years of age
• Glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 16 mm Hg.
• An aqueous shunt implant as planned surgical procedure
• A diagnosis of ocular hypertension, primary open angle glaucoma, primary angle closure glaucoma, or secondary glaucoma.

You may not qualify if:

• Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
• Pregnant or nursing women.
• No light perception vision.
• Uveitis secondary to Juvenile Idiopathic Arthritis
• Previous cyclodestructive procedure or previous aqueous shunt device implanted in the same eye
• Supero-temporal buckling or other external impediment to supero-temporal aqueous shunt implantation
• Silicone oil-filled eyes or sufficient residual intraocular silicone oil to preclude supero-temporal aqueous shunt implantation
• Vitreous present in the anterior chamber, sufficient to require a vitrectomy at the time of surgery
• Condition with high episcleral pressure, such as Sturge-Weber or nanophthalmos
• Acute trauma (within 3 months)
• Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery.

Sponsors & Collaborators

• University of Sydney: lead

Study Sites (4)

Sydney Eye Hospital

Sydney, New South Wales, 2000, Australia

Location

Westmead Hospital

Sydney, New South Wales, 2145, Australia

Location

Liverpool Hospital

Sydney, New South Wales, 2170, Australia

Location

Royal Victorian Eye and Ear Hospital

Melbourne, Victoria, 3000, Australia

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Glaucoma Drainage Implants

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Central Study Contacts

Eamonn T Fahy, MBBCh PhD FRANZCO

CONTACT

+61 2 9382 7111; eamonn.fahy@sydney.edu.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The BvP Study is a 5-year, Phase 4, randomised, unblinded, comparative study to compare the Baerveldt Glaucoma Implant (BGI) and the Paul Glaucoma Implant (PGI) in patients undergoing aqueous shunt surgery. Patients who are planned for aqueous shunt surgery will be randomised to one of two groups, to receive implantation of either a BGI or PGI.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): October 12, 2026
• Primary Completion (Estimated): April 1, 2033
• Study Completion (Estimated): April 1, 2033
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)