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Baerveldt Plate Area Comparison (BPAC) (BPAC)

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ClinicalTrials.gov Identifier: NCT01159314
Recruitment Status : Terminated (Inadequate recruitment)
First Posted : July 9, 2010
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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 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 or disease Intervention/treatment Phase
Glaucoma Procedure: Baerveldt Device surgical Procedure Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Baerveldt Plate Area Comparison (BPAC)
Study Start Date : June 2010
Actual Primary Completion Date : December 4, 2017
Actual Study Completion Date : December 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Visual Acuity as assessed by Early Treatment Diabetic Retinopathy Study (EDTRS) [ Time Frame: Up to 5 years ]
    Visual acuity is an important outcome variable in the BPAC. Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing will be employed at the Qualifying Assessment and at every follow-up visit.The patient starts are the top of the chart and begins to read down the chart. The patient reads down the chart until he or she reaches a row where a minimum of three letters on a line cannot be read. The patient is scored by how many letters could be correctly identified. ETDRS visual acuity is required at the Qualifying Assessment and at the 1 year, 3 year, and 5 year follow-up visits



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159314


Locations
United States, California
University of California - Davis
Sacramento, California, United States, 95817-2307
United States, Florida
U. Miami/Bascom Palmer
Miami, Florida, United States, 33136
United States, Maryland
The Wilmer Eye Institute
Baltimore, Maryland, United States, 21287
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, Pennsylvania
Wills Eye Institute
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Michael Boland, MD, PhD Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01159314     History of Changes
Other Study ID Numbers: NA_00037146
First Posted: July 9, 2010    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018

Keywords provided by Johns Hopkins University:
glaucoma
Baerveldt Implants

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases