Baerveldt Plate Area Comparison (BPAC)

NCT01159314 | Terminated DMC

• 1 other identifier: NA_00037146
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 5

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.

Conditions

Glaucoma

Keywords

glaucoma; Baerveldt Implants

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Arm A - Baerveldt 250 mm2

EXPERIMENTAL

Patients receiving Baerveldt 250 mm2

Procedure: Baerveldt Device surgical Procedure

Arm B - Baerveldt 350 mm2

EXPERIMENTAL

Patients receiving Baerveldt 350 mm2

Procedure: Baerveldt Device surgical Procedure

Interventions

Baerveldt Device surgical Procedure PROCEDURE

Implant surgery

Arm A - Baerveldt 250 mm2; Arm B - Baerveldt 350 mm2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (5)

University of California - Davis

Sacramento, California, 95817-2307, United States

Location

U. Miami/Bascom Palmer

Miami, Florida, 33136, United States

Location

The Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Wills Eye Institute

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Michael Boland, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 9, 2010
• Study Start: June 1, 2010
• Primary Completion: December 4, 2017
• Study Completion: December 4, 2017
• Last Updated: April 25, 2018

Record last verified: 2018-04

Locations

US (5)