A Phase 4 interventional study of Baerveldt Glaucoma Implant and Paul Glaucoma Implant in Glaucoma, sponsored by University of Sydney. Not yet recruiting at 4 sites in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by University of Sydney · Phase 4, Interventional, and Treatment
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.
Background and Rationale:
Glaucoma is a leading cause of irreversible blindness. Reduction of intraocular pressure (IOP) is the only proven modifiable factor for slowing glaucoma progression. Glaucoma drainage devices are commonly used when glaucoma is inadequately controlled with medical or laser treatment and when other glaucoma procedures are considered likely to fail.
The 350-mm² Baerveldt Glaucoma Implant (BGI) is an established non-valved glaucoma drainage device with demonstrated efficacy and safety in previous randomised clinical trials. The Paul Glaucoma Implant (PGI) is a newer non-valved device that uses a smaller-diameter tube. The PGI has been proposed to provide improved early postoperative IOP control and potentially reduce complications such as hypotony, corneal endothelial damage and tube exposure. However, these potential advantages have not been established in a prospective randomised comparison with the BGI. Existing comparative evidence is primarily retrospective and has not demonstrated a clear difference between the devices.
The Baerveldt versus Paul Study is designed to address this uncertainty by directly comparing the long-term safety and effectiveness of the BGI and PGI in patients requiring glaucoma drainage device surgery.
Study Design:
This is a multicentre, Phase 4, pragmatic, registry-based randomised controlled trial with five years of postoperative follow-up. Eligible study eyes will be randomised in a 1:1 ratio to implantation of either a 350-mm² Baerveldt Glaucoma Implant or a Paul Glaucoma Implant. Both devices are established treatments used in routine glaucoma care. Neither participants nor treating investigators will be masked to treatment allocation.
Randomisation will use randomly permuted blocks of variable size and will be stratified by clinical centre and glaucoma type. Glaucoma-type strata will include primary glaucoma or ocular hypertension, secondary glaucoma excluding uveitic and neovascular glaucoma, neovascular glaucoma, and uveitic glaucoma.
The trial will be conducted using the Fight Glaucoma Blindness! Registry within the Save Sight Registries platform. The registry-based design will support participant enrolment, collection of baseline and postoperative clinical data, monitoring of follow-up completeness, central data-quality checks, safety surveillance and statistical analysis. This approach is intended to integrate trial procedures into routine clinical care while maintaining the methodological safeguards of a randomised controlled trial.
Implantation will be performed in accordance with the study protocol. Accepted variations in surgical technique, including methods of tube occlusion, use of intraluminal stents or fenestrations and patch-graft material, may be selected by the operating surgeon and will be recorded prospectively in the registry.
Outcomes and Follow-up:
The principal objective is to compare surgical success and failure between the two treatment groups. Surgical failure is defined as IOP greater than 21 mmHg or less than 6 mmHg on two consecutive visits more than three months after surgery; less than a 20% reduction in IOP from baseline on two consecutive visits more than three months after surgery; additional glaucoma surgery; loss of light-perception vision; or removal of the implant for any reason.
Eyes that have not met a failure criterion and do not require glaucoma medication will be classified as complete successes. Eyes that have not failed but require supplemental glaucoma medication will be classified as qualified successes.
Additional outcomes will include IOP, number of glaucoma medications, visual acuity, visual-field outcomes, glaucoma reoperations, and intraoperative and postoperative complications. Safety outcomes will include hypotony, choroidal effusion, suprachoroidal haemorrhage, endophthalmitis, corneal oedema, tube or implant erosion, tube malposition, diplopia and other device- or procedure-related complications.
Follow-up is scheduled at postoperative day 1; week 1; months 1, 3, 6, 12 and 18; and annually from years 2 through 5. An independent Data and Safety Monitoring Board will review accumulating safety data, trial conduct and prespecified interim analyses.
1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.
This study's planned enrollment of 150 is above the median of 61 across 964 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →University of Sydney is the lead sponsor of 94 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Patients randomised to this arm will undergo insertion of a Baerveldt Glaucoma Implant.
Device: Baerveldt Glaucoma Implant
Patients randomised to this arm will undergo insertion of a Paul Glaucoma Implant.
Device: Paul Glaucoma Implant
Surgical insertion of an aqueous shunt for control of intraocular pressure and/or glaucoma
Surgical insertion of an aqueous shunt for control of intraocular pressure and/or glaucoma
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
Time frame: From enrollment until the end of follow up at 5 years postoperative.
Intraocular Pressure
Intraocular pressure measured by Goldmann Applanation Tonometry
Time frame: From enrollment until the end of follow up at 5 years postoperative.
Number of glaucoma medications
Number of glaucoma medications used
Time frame: From enrollment until the end of follow up at 5 years postoperative.
Visual acuity
Snellen chart visual acuity
Time frame: From enrollment until the end of follow up at 5 years postoperative.
Visual field outcomes
Visual field parameters, mean deviation and pattern standard deviation
Time frame: From enrollment until the end of follow up at 5 years postoperative.
Safety Outcomes
Records of complications (intraoperative and postoperative) and reoperations occurring in each treatment arm.
Time frame: From enrollment until the end of follow up at 5 years postoperative.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Apr 2033, 78 months later.
Of 32 non-industry phase 4 interventional studies under Glaucoma, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 78 months is above that.
Counting every sponsor, half of 44 studies reached it within 34 months; a quarter within 11 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University of Sydney