Baerveldt Glaucoma Implant: Surgical insertion of an aqueous shunt for control of intraocular pressure and/or glaucoma
Paul Glaucoma Implant: Surgical insertion of an aqueous shunt for control of intraocular pressure and/or glaucoma
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
1. Age ≥ 18 years of age
2. Glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 16 mm Hg.
3. An aqueous shunt implant as planned surgical procedure
4. A diagnosis of ocular hypertension, primary open angle glaucoma, primary angle closure glaucoma, or secondary glaucoma.
Exclusion Criteria:
1. Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
2. Pregnant or nursing women.
3. No light perception vision.
4. Uveitis secondary to Juvenile Idiopathic Arthritis
5. Previous cyclodestructive procedure or previous aqueous shunt device implanted in the same eye
6. Supero-temporal buckling or other external impediment to supero-temporal aqueous shunt implantation
7. Silicone oil-filled eyes or sufficient residual intraocular silicone oil to preclude supero-temporal aqueous shunt implantation
8. Vitreous present in the anterior chamber, sufficient to require a vitrectomy at the time of surgery
9. Condition with high episcleral pressure, such as Sturge-Weber or nanophthalmos
10. Acute trauma (within 3 months)
11. 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.
Primary outcome measure(s)
Surgical Failure — From enrollment until the end of follow up at 5 years postoperative. 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.