Baerveldt Plate Area Comparison (BPAC)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Glaucoma |
Procedure: Baerveldt Device surgical Procedure |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Baerveldt Plate Area Comparison (BPAC) |
- Visual Acuity [ Time Frame: Annual follow-up visits ] [ Designated as safety issue: No ]Visual acuity is an important outcome variable in the BPAC. Visual acuity is measured before pupil dilation, tonometry, gonioscopy, or any other technique that could affect vision. Two different techniques are used to measure visual acuity, including Snellen and ETDRS visual acuity testing. Visual acuity is measured at the Qualifying Assessment and at every follow-up visit. ETDRS visual acuity is required at the Qualifying Assessment and at the 1 year, 3 year, and 5 year follow-up visits
| Estimated Enrollment: | 270 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A - Baerveldt 250 mm2
Patients receiving Baerveldt 250 mm2
|
Procedure: Baerveldt Device surgical Procedure
Implant surgery
|
|
Experimental: Arm B - Baerveldt 350 mm2
Patients receiving Baerveldt 350 mm2
|
Procedure: Baerveldt Device surgical Procedure
Implant surgery
|
Detailed Description:
Inclusion criteria (must have all of the following):
- Age over 18 Y N
- IOP > 18 mm Hg and < 40 mm Hg on medical therapy Y N
- Previous ocular surgery limited to cataract, corneal transplant, trabeculectomy, vitrectomy Y N
- Consent signed Y N
Exclusion criteria (cannot have any of the following):
- Unwilling or unable to give consent, unwilling to accept randomization, or unable to Y N return for scheduled protocol visits
- Pregnant or nursing Y N
- NLP vision Y N
- Iris neovascularization or proliferative retinopathy Y N
- Iridocorneal endothelial syndrome Y N
- Epithelial or fibrous downgrowth Y N
- Chronic or recurrent uveitis Y N
- Steroid-induced glaucoma Y N
- Severe posterior blepharitis Y N
- Previous cyclodestructive procedure Y N
- Conjunctival scarring from prior ocular trauma or cicatrizing disease (e.g. Stevens Johnson syndrome, ocular pemphigoid) precluding Baerveldt implantation. Y N
- Functionally significant cataract Y N
- Need for Baerveldt implant combined with other ocular procedures (ie cataract surgery, Y N penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery
- Prior glaucoma drainage device (tube) implant Y N
- Prior retinal surgery with remaining silicone oil Y N
- Prior scleral buckling procedures
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age over 18
- 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
- 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
Contacts and Locations| Contact: Michael Boland, MD, Ph.D. | 410-502-4074 | boland@jhu.edu |
| Contact: Rhonda B Miller, COA | 410-955-1779 | rhbmiller@jhmi.edu |
| United States, California | |
| University of California - Davis | Recruiting |
| Sacramento, California, United States, 95817-2307 | |
| Contact: James D Brandt, MD 916-734-6969 jbrandt@uddavis.edu | |
| Principal Investigator: James D Brandt, MD | |
| United States, Florida | |
| U. Miami/Bascom Palmer | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Sarah Wellik, MD SWellik@med.miami.edu | |
| Principal Investigator: Sarah Wellik, MD | |
| Sub-Investigator: Richard Lee, MD | |
| United States, Maryland | |
| The Wilmer Eye Institute | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Michael Boland, Md, Ph.D 410-502-4074 boland@jhmi.edu | |
| Contact: Rhonda B Miller, COA 410-955-1779 rhbmiller@jhmi.edu | |
| Sub-Investigator: Henry D Jampel, MD, MHS | |
| Sub-Investigator: Harry Quigley, MD | |
| Sub-Investigator: Pradeep Ramulu, MD | |
| Sub-Investigator: David S Friedman, MD, MPH | |
| United States, New York | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Janet Serle, MD 212-241-8979 janet.serle@mssm.edu | |
| Principal Investigator: Janet Serle, MD | |
| United States, Pennsylvania | |
| Wills Eye Institute | Recruiting |
| Philadelphia, Pennsylvania, United States | |
| Contact: Jonathan Myers, MD jmyers@willseye.org | |
| Principal Investigator: Jonathan Myers, MD | |
| Sub-Investigator: Marlene Moster, MD | |
| Principal Investigator: | Michael Boland, MD, PhD | Johns Hopkins Medicine |
More Information
No publications provided
| Responsible Party: | Michael V. Boland, M.D., Ph.D, Assistant Professor, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT01159314 History of Changes |
| Other Study ID Numbers: | NA_00037146 |
| Study First Received: | July 8, 2010 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
|
glaucoma Baerveldt Implants |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases |
ClinicalTrials.gov processed this record on June 13, 2013