Ahmed Versus Baerveldt Comparison Study

Completed · Not applicable

Conditions studied: Glaucoma

In brief

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.

Key facts

Study ID

NCT00376363

Run by

University of Miami

People needed

276

Starts

2005-11-01

Expected to finish

2014-10-01

Last updated by the study team

2015-08-20

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Miami, Bascom Palmer Eye Institute — Miami, Florida, United States

Full record on ClinicalTrials.gov

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