NCT00376363

Brief Summary

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. One eye of 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2006

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
8 months until next milestone

Results Posted

Study results publicly available

June 4, 2015

Completed
Last Updated

August 20, 2015

Status Verified

July 1, 2015

Enrollment Period

8.1 years

First QC Date

September 13, 2006

Results QC Date

May 17, 2015

Last Update Submit

July 25, 2015

Conditions

Glaucoma

Keywords

glaucomaAhmed implantBaerveldt implant

Outcome Measures

Primary Outcomes (2)

  • Intraocular Pressure

    intraocular pressure mmHg at 5 years

    5 years

  • Failure Rate

    5-year failure rate measured by Kaplan-Meier, defined as IOP\>21 mm Hg or less than a 20% reduction below baseline on 2 consecutive study visits after 3 months, reoperation for glaucoma, loss of light perception, or removal of implant

    5 years

Secondary Outcomes (1)

  • Visual Acuity

    5 years

Study Arms (2)

Ahmed implant,1

ACTIVE COMPARATOR

Ahmed glaucoma drainage implant for intraocular pressure control

Device: Ahmed implant

Baerveldt implant

ACTIVE COMPARATOR

Baerveldt glaucoma drainage implant for intraocular pressure control

Device: Baerveldt implant

Interventions

Ahmed implantDEVICE

placement of glaucoma drainage device to control intraocular pressure

Also known as: Ahmed fp7
Ahmed implant,1
Baerveldt implantDEVICE

placement of glaucoma drainage device to control intraocular press

Also known as: Baerveldt 350
Baerveldt implant

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami, Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Related Publications (11)

  • Coleman AL, Hill R, Wilson MR, Choplin N, Kotas-Neumann R, Tam M, Bacharach J, Panek WC. Initial clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol. 1995 Jul;120(1):23-31. doi: 10.1016/s0002-9394(14)73755-9.

    PMID: 7611326BACKGROUND

  • Topouzis F, Coleman AL, Choplin N, Bethlem MM, Hill R, Yu F, Panek WC, Wilson MR. Follow-up of the original cohort with the Ahmed glaucoma valve implant. Am J Ophthalmol. 1999 Aug;128(2):198-204. doi: 10.1016/s0002-9394(99)00080-x.

    PMID: 10458176BACKGROUND

  • Lloyd MA, Baerveldt G, Fellenbaum PS, Sidoti PA, Minckler DS, Martone JF, LaBree L, Heuer DK. Intermediate-term results of a randomized clinical trial of the 350- versus the 500-mm2 Baerveldt implant. Ophthalmology. 1994 Aug;101(8):1456-63; discussion 1463-4. doi: 10.1016/s0161-6420(94)31152-3.

    PMID: 8058290BACKGROUND

  • Britt MT, LaBree LD, Lloyd MA, Minckler DS, Heuer DK, Baerveldt G, Varma R. Randomized clinical trial of the 350-mm2 versus the 500-mm2 Baerveldt implant: longer term results: is bigger better? Ophthalmology. 1999 Dec;106(12):2312-8. doi: 10.1016/S0161-6420(99)90532-8.

    PMID: 10599663BACKGROUND

  • Wang JC, See JL, Chew PT. Experience with the use of Baerveldt and Ahmed glaucoma drainage implants in an Asian population. Ophthalmology. 2004 Jul;111(7):1383-8. doi: 10.1016/j.ophtha.2003.11.005.

    PMID: 15234141BACKGROUND

  • Tsai JC, Johnson CC, Dietrich MS. The Ahmed shunt versus the Baerveldt shunt for refractory glaucoma: a single-surgeon comparison of outcome. Ophthalmology. 2003 Sep;110(9):1814-21. doi: 10.1016/S0161-6420(03)00574-8.

    PMID: 13129882BACKGROUND

  • Nguyen QH, Budenz DL, Parrish RK 2nd. Complications of Baerveldt glaucoma drainage implants. Arch Ophthalmol. 1998 May;116(5):571-5. doi: 10.1001/archopht.116.5.571.

    PMID: 9596491BACKGROUND

  • Barton K, Gedde SJ, Budenz DL, Feuer WJ, Schiffman J; Ahmed Baerveldt Comparison Study Group. The Ahmed Baerveldt Comparison Study methodology, baseline patient characteristics, and intraoperative complications. Ophthalmology. 2011 Mar;118(3):435-42. doi: 10.1016/j.ophtha.2010.07.015. Epub 2010 Oct 8.

    PMID: 20932581RESULT

  • Budenz DL, Barton K, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, Buys YM; Ahmed Baerveldt Comparison Study Group. Treatment outcomes in the Ahmed Baerveldt Comparison Study after 1 year of follow-up. Ophthalmology. 2011 Mar;118(3):443-52. doi: 10.1016/j.ophtha.2010.07.016. Epub 2010 Oct 8.

    PMID: 20932583RESULT

  • Barton K, Feuer WJ, Budenz DL, Schiffman J, Costa VP, Godfrey DG, Buys YM; Ahmed Baerveldt Comparison Study Group. Three-year treatment outcomes in the Ahmed Baerveldt comparison study. Ophthalmology. 2014 Aug;121(8):1547-57.e1. doi: 10.1016/j.ophtha.2014.01.036. Epub 2014 Apr 24.

    PMID: 24768240RESULT

  • Budenz DL, Barton K, Gedde SJ, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, Buys YM; Ahmed Baerveldt Comparison Study Group. Five-year treatment outcomes in the Ahmed Baerveldt comparison study. Ophthalmology. 2015 Feb;122(2):308-16. doi: 10.1016/j.ophtha.2014.08.043. Epub 2014 Oct 17.

    PMID: 25439606RESULT

MeSH Terms

Conditions

Glaucoma

Interventions

Glaucoma Drainage Implants

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Results Point of Contact

Title
Donald Budenz
Organization
University of North Carolina
donald_budenz@med.unc.edu
919-843-0297

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Chairman

Study Record Dates

First Submitted

September 13, 2006

First Posted

September 14, 2006

Study Start

November 1, 2005

Primary Completion

December 1, 2013

Study Completion

October 1, 2014

Last Updated

August 20, 2015

Results First Posted

June 4, 2015

Record last verified: 2015-07

Locations

US(1)