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NCT01159314 · ClinicalTrials.gov registry record · NA
Baerveldt Plate Area Comparison (BPAC)
A NA study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- NA
- Development phase
- 69
- Enrollment target
NCT01159314: Clinical Trial NA study, sponsored by Johns Hopkins University.
NCT01159314 is a NA study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 69 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01159314, a NA study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- NA
- Development phase
- 69 participants
- Enrollment target
Study 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.
Primary Outcome
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 acuit
Interventions
- PROCEDURE Baerveldt Device surgical Procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2010-06 |
| Est. Completion | 2017-12-04 |
| Phase | NA |
Why NCT01159314 stopped before completion
NCT01159314 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Baerveldt Device surgical Procedure is the first listed.
NCT01159314 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01159314 about?
NCT01159314 is a clinical study titled "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 dec...
What is the current status of trial NCT01159314?
This trial is currently terminated. It is a NA study. The enrollment target is 69 participants. The study started on 2010-06. Estimated completion is 2017-12-04.
What interventions are being tested in trial NCT01159314?
The interventions under investigation include: Baerveldt Device surgical Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT01159314?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01159314's enrollment target sits among peer trials
69 1133rd of 2000 higher than 868 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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