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Baerveldt Plate Area Comparison (BPAC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Michael V. Boland, M.D., Ph.D, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01159314
First received: July 8, 2010
Last updated: April 1, 2013
Last verified: April 2013
  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)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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):

  1. Age over 18 Y N
  2. IOP > 18 mm Hg and < 40 mm Hg on medical therapy Y N
  3. Previous ocular surgery limited to cataract, corneal transplant, trabeculectomy, vitrectomy Y N
  4. Consent signed Y N

Exclusion criteria (cannot have any of the following):

  1. Unwilling or unable to give consent, unwilling to accept randomization, or unable to Y N return for scheduled protocol visits
  2. Pregnant or nursing Y N
  3. NLP vision Y N
  4. Iris neovascularization or proliferative retinopathy Y N
  5. Iridocorneal endothelial syndrome Y N
  6. Epithelial or fibrous downgrowth Y N
  7. Chronic or recurrent uveitis Y N
  8. Steroid-induced glaucoma Y N
  9. Severe posterior blepharitis Y N
  10. Previous cyclodestructive procedure Y N
  11. Conjunctival scarring from prior ocular trauma or cicatrizing disease (e.g. Stevens Johnson syndrome, ocular pemphigoid) precluding Baerveldt implantation. Y N
  12. Functionally significant cataract Y N
  13. 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
  14. Prior glaucoma drainage device (tube) implant Y N
  15. Prior retinal surgery with remaining silicone oil Y N
  16. Prior scleral buckling procedures
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159314

Contacts
Contact: Michael Boland, MD, Ph.D. 410-502-4074 boland@jhu.edu
Contact: Rhonda B Miller, COA 410-955-1779 rhbmiller@jhmi.edu

Locations
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         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 25, 2014