Clinical trial NCT01159314: Baerveldt Plate Area Comparison (BPAC)
Official title: Baerveldt Plate Area Comparison (BPAC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glaucoma
Keywords: glaucoma
Baerveldt Implants
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2010-07-09
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is being done to compare the safety and effectiveness of two sizes of the Baerveldt glaucoma implant.

A Baerveldt glaucoma implant is one of the most common types of glaucoma operations performed. This procedure works by providing a route by which fluid can drain out of the eye to decrease the intraocular pressure. The Baerveldt implant does this by placing a tube into the eye which shunts aqueous fluid to a silicone plate which is attached to the sclera (white portion of the eye). It is this plate that comes in two different sizes (250 square millimeters and 350 square millimeters).

Earlier studies have shown that larger plate sizes produce lower eye pressures but that they may also result in more complications. While both Baerveldt devices are currently in use and have been shown to be safe and effective, it is unclear if one is superior to the other. The purpose of this study is to see if one size of device works better with fewer complications.


Eligibility criteria: Inclusion Criteria:

* Age over 18
* Intra-Ocular Pressure (IOP) \> 18 mm Hg and \< 40 mm Hg on medical therapy
* Previous ocular surgery limited to (cataract, corneal transplant, trabeculectomy, vitrectomy)
* Consent signed

Exclusion Criteria:

* Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
* Pregnant or nursing
* Neuro-Linguistic Programming (NLP) vision
* Iris neovascularization or proliferative retinopathy
* Epithelial or fibrous downgrowth
* Chronic or recurrent uveitis
* Steroid-induced glaucoma
* Severe posterior blepharitis
* Previous cyclodestructive procedure
* Conjunctival scarring from prior ocular trauma or cicatrizing disease (e.g. Stevens Johnson syndrome, ocular pemphigoid) precluding Baerveldt implantation.
* Functionally significant cataract
* Need for Baerveldt implant combined with other ocular procedures (ie cataract surgery,penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery
* Prior glaucoma drainage device (tube) implant
* Prior retinal surgery with remaining silicone oil
* Prior scleral buckling procedures

Primary outcomes:
measure: Visual Acuity as assessed by Early Treatment Diabetic Retinopathy Study (EDTRS)
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California - Davis
state: California
city: Miami
country: United States
facility: U. Miami/Bascom Palmer
state: Florida
city: Baltimore
country: United States
facility: The Wilmer Eye Institute
state: Maryland
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Philadelphia
country: United States
facility: Wills Eye Institute
state: Pennsylvania
Study officials:
affiliation: Johns Hopkins University
name: Michael Boland, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: