Status:
TERMINATED
Baerveldt Plate Area Comparison (BPAC)
Lead Sponsor:
Johns Hopkins University
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2017
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01159314
Start Date
June 1 2010
End Date
December 4 2017
Last Update
April 25 2018
Active Locations (5)
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1
University of California - Davis
Sacramento, California, United States, 95817-2307
2
U. Miami/Bascom Palmer
Miami, Florida, United States, 33136
3
The Wilmer Eye Institute
Baltimore, Maryland, United States, 21287
4
Mount Sinai School of Medicine
New York, New York, United States, 10029