Status:
COMPLETED
Ahmed Versus Baerveldt Comparison Study
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Eye Institute (NEI)
Research to Prevent Blindness
Conditions:
Glaucoma
Eligibility:
All Genders
18-85 years
Phase:
NA
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 o...
Detailed Description
Background and Significance Aqueous shunt devices have traditionally been reserved for treatment of only the most refractory glaucomas. However, more recent studies have reported favorable results in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT00376363
Start Date
November 1 2005
End Date
October 1 2014
Last Update
August 20 2015
Active Locations (1)
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1
University of Miami, Bascom Palmer Eye Institute
Miami, Florida, United States, 33136