NCT07733453Not yet recruitingPhase 4
Baerveldt Versus Paul Study
The Baerveldt Versus Paul (BvP) Study: a Registry-based Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 24 Jul 2026
- Start date
- 12 Oct 2026
- Primary completion date
- Apr 2033
- Lead sponsor
- University of Sydney
- Diseases
- Glaucoma
- NCT number
- NCT07733453
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 150
- From 12 Oct 2026 to the primary completion date, Apr 2033
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous cyclodestructive procedure or previous aqueous shunt device implanted in the same eye
- Vitreous present in the anterior chamber, sufficient to require a vitrectomy at the time of surgery
- 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.
Other illness
- Condition with high episcleral pressure, such as Sturge-Weber or nanophthalmos
Other
- 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
- 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
- Acute trauma (within 3 months)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Victorian Eye and Ear Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Sydney Eye Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Westmead Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Liverpool Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.