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Baerveldt Plate Area Comparison (BPAC) (BPAC)

Primary Purpose

Glaucoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Baerveldt Device surgical Procedure
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, Baerveldt Implants

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California - Davis
  • U. Miami/Bascom Palmer
  • The Wilmer Eye Institute
  • Mount Sinai School of Medicine
  • Wills Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A - Baerveldt 250 mm2

Arm B - Baerveldt 350 mm2

Arm Description

Patients receiving Baerveldt 250 mm2

Patients receiving Baerveldt 350 mm2

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 8, 2010
Last Updated
April 23, 2018
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01159314
Brief Title
Baerveldt Plate Area Comparison (BPAC)
Acronym
BPAC
Official Title
Baerveldt Plate Area Comparison (BPAC)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Inadequate recruitment
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 4, 2017 (Actual)
Study Completion Date
December 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, Baerveldt Implants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A - Baerveldt 250 mm2
Arm Type
Experimental
Arm Description
Patients receiving Baerveldt 250 mm2
Arm Title
Arm B - Baerveldt 350 mm2
Arm Type
Experimental
Arm Description
Patients receiving Baerveldt 350 mm2
Intervention Type
Procedure
Intervention Name(s)
Baerveldt Device surgical Procedure
Intervention Description
Implant surgery
Primary Outcome Measure Information:
Title
Visual Acuity as assessed by Early Treatment Diabetic Retinopathy Study (EDTRS)
Description
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
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Boland, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California - Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817-2307
Country
United States
Facility Name
U. Miami/Bascom Palmer
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
The Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Wills Eye Institute
City
Philadelphia
State/Province
Pennsylvania
Country
United States

12. IPD Sharing Statement

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