Baerveldt Plate Area Comparison (BPAC) (BPAC)

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.

Study Overview

• Status: Terminated
• Conditions: Glaucoma
• Intervention / Treatment: Procedure: Baerveldt Device surgical Procedure

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817-2307
      • University of California - Davis
  • Florida
    • Miami, Florida, United States, 33136
      • U. Miami/Bascom Palmer
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Wilmer Eye Institute
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • Wills Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity as assessed by Early Treatment Diabetic Retinopathy Study (EDTRS)	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	Up to 5 years

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Michael Boland, MD, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 4, 2017
• Study Completion (Actual): December 4, 2017

Study Registration Dates

• First Submitted: July 8, 2010
• First Submitted That Met QC Criteria: July 8, 2010
• First Posted (Estimate): July 9, 2010

Study Record Updates

• Last Update Posted (Actual): April 25, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: glaucoma; Baerveldt Implants
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: NA_00037146