Ahmed Versus Baerveldt Comparison (ABC) Study - Full Text View

Sponsors and Collaborators:	University of Miami National Eye Institute (NEI) Research to Prevent Blindness
Information provided by:	University of Miami
ClinicalTrials.gov Identifier:	NCT00376363

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 III

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Edema Glaucoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Ahmed Versus Baerveldt Comparison (ABC) Study

Further study details as provided by University of Miami:

Primary Outcome Measures:

intraocular pressure
reoperation for glaucoma
number of glaucoma medications
reoperation for ocular complication
diplopia

Secondary Outcome Measures:

visual acuity
visual field
endophthalmitis
suprachoroidal hemorrhage
choroidal effusion
corneal edema
shunt/tube erosion

Estimated Enrollment:	275
Study Start Date:	November 2005
Estimated Study Completion Date:	December 2012

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

Contacts

Contact: Donald L Budenz, M.D., M.P.H.	(305) 326-6384	dbudenz@med.miami.edu
Contact: William J Feuer, M.S.	(305) 326-6064	wfeuer@med.miami.edu

Locations

United States, Florida
University of Miami, Bascom Palmer Eye Institute	Recruiting
Miami, Florida, United States, 33136

Sponsors and Collaborators

University of Miami

National Eye Institute (NEI)

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:

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. Erratum in: Am J Ophthalmol. 1995 Nov;120(5):684.

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.

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.

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.

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.

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.

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

Study ID Numbers:	2005-1738, NEI grant EY014801
Study First Received:	September 13, 2006
Last Updated:	April 11, 2007
ClinicalTrials.gov Identifier:	NCT00376363
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Miami:

glaucoma
Ahmed implant
Baerveldt implant

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 15, 2009