Baerveldt Plate Area Comparison (BPAC)

Sponsor

Johns Hopkins University (Other)

Overall Status

Terminated

CT.gov ID

NCT01159314

Collaborator

(none)

Enrollment

Locations

Arms

90.1

Duration (Months)

13.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Procedure: Baerveldt Device surgical Procedure	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

69 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Baerveldt Plate Area Comparison (BPAC)

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Dec 4, 2017

Actual Study Completion Date :

Dec 4, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Visual Acuity as assessed by Early Treatment Diabetic Retinopathy Study (EDTRS) [Up to 5 years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California - Davis	Sacramento	California	United States	95817-2307
2	U. Miami/Bascom Palmer	Miami	Florida	United States	33136
3	The Wilmer Eye Institute	Baltimore	Maryland	United States	21287
4	Mount Sinai School of Medicine	New York	New York	United States	10029
5	Wills Eye Institute	Philadelphia	Pennsylvania	United States

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator: Michael Boland, MD, PhD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT01159314

Other Study ID Numbers:

NA_00037146

First Posted:

Jul 9, 2010

Last Update Posted:

Apr 25, 2018

Last Verified:

Apr 1, 2018

Keywords provided by Johns Hopkins University

glaucoma

Baerveldt Implants

Additional relevant MeSH terms:

Glaucoma

Study Results

No Results Posted as of Apr 25, 2018