Ahmed Versus Baerveldt Comparison Study (ABC)

This study has been completed.
Sponsor:
Collaborators:
Research to Prevent Blindness
Information provided by (Responsible Party):
Donald L. Budenz, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00376363
First received: September 13, 2006
Last updated: July 25, 2015
Last verified: July 2015
Results First Received: May 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Glaucoma
Interventions: Device: Ahmed implant
Device: Baerveldt implant

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 276 patients were enrolled between November 2005 and April 2008: 143 in the Ahmed group and 133 in the Baerveldt group at 16 clinical centers worldwide.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ahmed Implant,1

Ahmed glaucoma drainage implant for intraocular pressure control

Ahmed implant: placement of glaucoma drainage device to control intraocular pressure

Baerveldt Implant

Baerveldt glaucoma drainage implant for intraocular pressure control

Baerveldt implant: placement of glaucoma drainage device to control intraocular press


Participant Flow:   Overall Study
    Ahmed Implant,1     Baerveldt Implant  
STARTED     143     133  
COMPLETED     87     87  
NOT COMPLETED     56     46  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
One eye of each patient will be randomized to receive either an Ahmed or a Baerveldt glaucoma drainage implant.

Reporting Groups
  Description
Ahmed Implant,1

Ahmed glaucoma drainage implant for intraocular pressure control

Ahmed implant: placement of glaucoma drainage device to control intraocular pressure

Baerveldt Implant

Baerveldt glaucoma drainage implant for intraocular pressure control

Baerveldt implant: placement of glaucoma drainage device to control intraocular press

Total Total of all reporting groups

Baseline Measures
    Ahmed Implant,1     Baerveldt Implant     Total  
Number of Participants  
[units: participants]
  143     133     276  
Age  
[units: years]
Mean (Standard Deviation)
  65.4  (12.8)     62.2  (14.2)     63.8  (13.6)  
Gender  
[units: participants]
     
Female     70     63     133  
Male     73     70     143  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Intraocular Pressure   [ Time Frame: 5 years ]

2.  Primary:   Failure Rate   [ Time Frame: 5 years ]

3.  Secondary:   Visual Acuity   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Donald Budenz
Organization: University of North Carolina
phone: 919-843-0297
e-mail: donald_budenz@med.unc.edu


Publications of Results:
Other Publications:

Responsible Party: Donald L. Budenz, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00376363     History of Changes
Other Study ID Numbers: 20057138, P30EY014801
Study First Received: September 13, 2006
Results First Received: May 17, 2015
Last Updated: July 25, 2015
Health Authority: United States: Institutional Review Board