We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ahmed Versus Baerveldt Comparison Study (ABC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00376363
First Posted: September 14, 2006
Last Update Posted: August 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Eye Institute (NEI)
Research to Prevent Blindness
Information provided by (Responsible Party):
Donald L. Budenz, University of North Carolina, Chapel Hill
Results First Submitted: May 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Glaucoma
Interventions: Device: Ahmed implant
Device: Baerveldt implant

  Participant Flow
  Hide Participant Flow

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
No text entered.

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2006
First Posted: September 14, 2006
Results First Submitted: May 17, 2015
Results First Posted: June 4, 2015
Last Update Posted: August 20, 2015



To Top