Ahmed Versus Baerveldt Comparison (ABC) Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Miami.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Research to Prevent Blindness
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00376363
First received: September 13, 2006
Last updated: February 12, 2009
Last verified: February 2009
  Purpose

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 Phase
Glaucoma
Device: Ahmed implant
Device: Baerveldt implant
Phase 3

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 (ABC) 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
Estimated Study Completion Date: December 2013
Estimated 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

  Eligibility

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

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

Locations
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
Investigators
Principal Investigator: Donald L Budenz, M.D.,M.P.H. University of Miami
Principal Investigator: Keith Barton, M.D. Moorfields Eye Hospital NHS Foundation Trust
Principal Investigator: William J Feuer, M.S. University of Miami
  More Information

Publications:
Responsible Party: Donald L Budenz MD MPH, University of Miami
ClinicalTrials.gov Identifier: NCT00376363     History of Changes
Other Study ID Numbers: 2005-1738, NEI grant EY014801
Study First Received: September 13, 2006
Last Updated: February 12, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
glaucoma
Ahmed implant
Baerveldt implant

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014