Ahmed Versus Baerveldt Comparison Study (ABC)

This study has been completed.
Research to Prevent Blindness
Information provided by (Responsible Party):
Donald L. Budenz, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
First received: September 13, 2006
Last updated: October 14, 2014
Last verified: October 2014

The objective of this study is to compare the long-term safety and efficacy of the Ahmed and the Baerveldt implants in patients who are undergoing aqueous shunt implant surgery for glaucoma. Eligible patients will be randomized. Outcome measures include intraocular pressure, visual acuity, visual field, number of glaucoma medications, glaucoma reoperations, and complications, including suprachoroidal hemorrhage, endophthalmitis, choroidal effusion, diplopia, corneal edema, and shunt/tube erosion.

Condition Intervention
Device: Ahmed implant
Device: Baerveldt implant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ahmed Versus Baerveldt Comparison Study

Resource links provided by NLM:

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • intraocular pressure [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • reoperation for glaucoma [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • number of glaucoma medications [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • reoperation for ocular complication [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • diplopia [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • visual acuity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • visual field [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • endophthalmitis [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • suprachoroidal hemorrhage [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • choroidal effusion [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • corneal edema [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • shunt/tube erosion [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 276
Study Start Date: November 2005
Study Completion Date: October 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ahmed implant,1
Ahmed glaucoma drainage implant for intraocular pressure control
Device: Ahmed implant
placement of glaucoma drainage device to control intraocular pressure
Other Name: Ahmed fp7
Active Comparator: Baerveldt implant
Baerveldt glaucoma drainage implant for intraocular pressure control
Device: Baerveldt implant
placement of glaucoma drainage device to control intraocular press
Other Name: Baerveldt 350

  Show Detailed Description


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 to 85 years, inclusive.
  • Glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg.
  • Glaucoma drainage implant as planned surgical procedure.
  • POAG with previous failed trabeculectomy or other intraocular surgery.
  • Secondary glaucoma with or without previous intraocular surgery

Exclusion Criteria:

  • Unwilling or unable to give consent or unwilling to accept randomization.
  • Patient out of area and potentially unavailable for follow-up visits
  • No light perception.
  • Uveitis secondary to Juvenile Idiopathic Arthritis
  • Previous cyclodestructive procedure or previous aqueous shunt device implanted in the same eye.
  • Supero-temporal buckling or other external impediment to supero-temporal aqueous shunt implantation.
  • Silicone oil-filled eyes or sufficient residual intraocular silicone oil to preclude supero-temporal aqueous shunt implantation.
  • Vitreous sufficient to require a vitrectomy present in the anterior chamber at the time of surgery.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376363

United States, Florida
University of Miami, Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Research to Prevent Blindness
Principal Investigator: Donald L Budenz, M.D.,M.P.H. University of North Carolina
Principal Investigator: Keith Barton, M.D. Moorfields Eye Hospital NHS Foundation Trust
Principal Investigator: William J Feuer, M.S. University of Miami
  More Information

Responsible Party: Donald L. Budenz, Study Chairman, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00376363     History of Changes
Other Study ID Numbers: 2005-1738, P30EY014801
Study First Received: September 13, 2006
Last Updated: October 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Ahmed implant
Baerveldt implant

ClinicalTrials.gov processed this record on March 26, 2015