Baerveldt Plate Area Comparison (BPAC)

Stopped early · Not applicable

Conditions studied: Glaucoma

In brief

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.

Key facts

Study ID

NCT01159314

Run by

Johns Hopkins University

People needed

69

Starts

2010-06-01

Expected to finish

2017-12-04

Last updated by the study team

2018-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California - Davis — Sacramento, California, United States
• U. Miami/Bascom Palmer — Miami, Florida, United States
• The Wilmer Eye Institute — Baltimore, Maryland, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Wills Eye Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.