Baerveldt Versus Paul Study
ConditionGlaucoma
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sydney
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Baerveldt Glaucoma Implant
DeviceSurgical insertion of an aqueous shunt for control of intraocular pressure and/or glaucoma
Paul Glaucoma Implant
DeviceSurgical insertion of an aqueous shunt for control of intraocular pressure and/or glaucoma
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Baerveldt Glaucoma ImplantActive comparator 1 intervention
Group B: Paul Glaucoma ImplantActive comparator 1 intervention
Trial outcomes
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
Time frame
From enrollment until the end of follow up at 5 years postoperative.Secondary outcomes
1
Intraocular Pressure
Intraocular pressure measured by Goldmann Applanation Tonometry
Time frame
From enrollment until the end of follow up at 5 years postoperative.2
Number of glaucoma medications
Number of glaucoma medications used
Time frame
From enrollment until the end of follow up at 5 years postoperative.3
Visual acuity
Snellen chart visual acuity
Time frame
From enrollment until the end of follow up at 5 years postoperative.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: