Baerveldt Plate Area Comparison (BPAC)
| Status: | Terminated |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/27/2018 |
| Start Date: | June 2010 |
| End Date: | December 4, 2017 |
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.
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.
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
We found this trial at
5
sites
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University of California-Davis As we begin our second century, UC Davis is poised to become...
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