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Baerveldt Plate Area Comparison (BPAC) (BPAC)

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ClinicalTrials.gov Identifier: NCT01159314
Recruitment Status : Terminated (Inadequate recruitment)
First Posted : July 9, 2010
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

July 8, 2010
July 9, 2010
April 25, 2018
June 2010
December 4, 2017   (Final data collection date for primary outcome measure)
Visual Acuity as assessed by Early Treatment Diabetic Retinopathy Study (EDTRS) [ Time Frame: 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
Visual Acuity [ Time Frame: Annual follow-up visits ]
Visual acuity is an important outcome variable in the BPAC. Visual acuity is measured before pupil dilation, tonometry, gonioscopy, or any other technique that could affect vision. Two different techniques are used to measure visual acuity, including Snellen and ETDRS visual acuity testing. Visual acuity is measured at the Qualifying Assessment and at every follow-up visit. ETDRS visual acuity is required at the Qualifying Assessment and at the 1 year, 3 year, and 5 year follow-up visits
Complete list of historical versions of study NCT01159314 on ClinicalTrials.gov Archive Site
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Baerveldt Plate Area Comparison (BPAC)
Baerveldt Plate Area Comparison (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.

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Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Glaucoma
Procedure: Baerveldt Device surgical Procedure
Implant surgery
  • Experimental: Arm A - Baerveldt 250 mm2
    Patients receiving Baerveldt 250 mm2
    Intervention: Procedure: Baerveldt Device surgical Procedure
  • Experimental: Arm B - Baerveldt 350 mm2
    Patients receiving Baerveldt 350 mm2
    Intervention: Procedure: Baerveldt Device surgical Procedure
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
69
270
December 4, 2017
December 4, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01159314
NA_00037146
Yes
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Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Michael Boland, MD, PhD Johns Hopkins University
Johns Hopkins University
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP