Baerveldt Plate Area Comparison (BPAC)

Glaucoma Clinical Trial

— BPAC  

Official title:

Baerveldt Plate Area Comparison (BPAC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01159314
• Other study ID #: NA_00037146
• Status: Terminated
• Phase: N/A
• First received: July 8, 2010
• Last updated: April 23, 2018
• Start date: June 2010
• Est. completion date: December 4, 2017

Study information

• Verified date: April 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 69
• Est. completion date: December 4, 2017
• Est. primary completion date: December 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• Baerveldt Device surgical Procedure
Implant surgery

Locations

Country	Name	City	State
United States	The Wilmer Eye Institute	Baltimore	Maryland
United States	U. Miami/Bascom Palmer	Miami	Florida
United States	Mount Sinai School of Medicine	New York	New York
United States	Wills Eye Institute	Philadelphia	Pennsylvania
United States	University of California - Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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