Baerveldt Plate Area Comparison (BPAC)

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Johns Hopkins University

Status

Terminated

Conditions

Glaucoma

Treatments

Procedure: Baerveldt Device surgical Procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT01159314
NA_00037146

Details and patient eligibility

About

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.

Enrollment

69 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

69 participants in 2 patient groups

Arm A - Baerveldt 250 mm2
Experimental group
Description:
Patients receiving Baerveldt 250 mm2
Treatment:
Procedure: Baerveldt Device surgical Procedure
Arm B - Baerveldt 350 mm2
Experimental group
Description:
Patients receiving Baerveldt 350 mm2
Treatment:
Procedure: Baerveldt Device surgical Procedure

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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