N/A
Completed N=276
Ahmed Versus Baerveldt Comparison Study
Source: ClinicalTrials.gov NCT00376363 ↗Enrolled (actual)
276
Serious AEs
9.1%
Results posted
Jun 2015
Primary outcomePrimary: Intraocular Pressure — 14.7; 12.7 mm Hg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure |
14.7; 12.7 | — |
| PRIMARY Failure Rate |
80; 53 | — |
| SECONDARY Visual Acuity |
1.42; 1.43 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00376363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.