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Purpose To determine the relative efficacy and complications of the Ahmed FP7 Glaucoma Valve (AGV) and the Baerveldt 101–350 Glaucoma Implant (BGI) in refractory glaucoma. Design Multicenter randomized controlled clinical trial. Participants 276 patients, including 143 in the AGV group and 133 in the BGI group. Methods Patients aged 18–85 years with refractory glaucoma with intraocular pressure (IOP) greater than or equal to 18 mm Hg in whom an aqueous shunt was planned were randomized to undergo implantation of either an AGV or a BGI. Main Outcome Measures Primary outcome was failure, defined as IOP > 21 mm Hg or not reduced by 20%, IOP ≤ 5 mm Hg, reoperation for glaucoma or removal of implant, or loss of light perception vision. Secondary outcomes included mean IOP, visual acuity, use of supplemental medical therapy, and complications. Results Preoperative IOP (mean ± standard deviation, SD) was 31.2 ± 11.2 in the AGV group and 31.8 ± 12.5 in the BGI group (p = 0.71). At 1 year, IOP was 15.4 ± 5.5 mm Hg in the AGV group and 13.2 ± 6.8 mm Hg in the BGI group (p = 0.007). The number of glaucoma medications (mean ± SD) was 1.8 ± 1.3 in the AGV group and 1.5 ± 1.4 in the BGI group (p = 0.071). The cumulative probability of failure was 16.4% (standard error, SE = 3.1%) in the AGV group and 14.0% (SE = 3.1%) in the BGI group at 1 year (p = 0.52). More patients experienced early postoperative complications in the BGI group (n = 77, 58%) compared to the AGV group (n = 61, 43%, p = 0.016). Serious postoperative complications associated with reoperation and/or vision loss of ≥ 2 Snellen lines occurred in 29 patients (20%) in the AGV group and 45 patients (34%) in the BGI group (p = 0.014). Conclusions Although the average IOP after one year was slightly higher in patients who received an AGV, there were fewer early and serious postoperative complications associated with the use of the AGV than the BGI.

OSD is prevalent among medically treated patients with glaucoma. The severity of OSD symptoms is positively correlated to the number of IOP-lowering medications used.

Purpose To compare the five year outcomes of the Ahmed FP7 Glaucoma Valve (AGV) and the Baerveldt 101-350 Glaucoma Implant (BGI) for the treatment of refractory glaucoma. Design Multicenter randomized controlled clinical trial. Participants 276 patients, including 143 in the AGV group and 133 in the BGI group. Methods Patients 18 to 85 years of age with previous intraocular surgery or refractory glaucoma and intraocular pressure (IOP) of ≥ 18 mmHg in whom glaucoma drainage implant surgery was planned were randomized to implantation of either an AGV or BGI. Main Outcome Measures IOP, visual acuity, use of glaucoma medications, complications, and failure (IOP > 21 mmHg or not reduced by 20% from baseline, IOP ≤ 5 mmHg, reoperation for glaucoma, removal of implant, or loss of light perception). Results At 5 years, IOP (mean ± SD) was 14.7 ± 4.4 mmHg in the AGV group and 12.7 ± 4.5 mmHg in the BGI group (p = 0.012). The number of glaucoma medications in use at 5 years (mean ± SD) was 2.2 ± 1.4 in the AGV group and 1.8 ± 1.5 in the BGI group (p = 0.28). The cumulative probability of failure during 5 years of follow-up was 44.7% in the AGV group and 39.4% in the BGI group (p = 0.65). The number of subjects failing due to inadequately controlled IOP or reoperation for glaucoma was 46 in the AGV group (80% of AGV failures) and 25 in the BGI group (53% of BGI failures, p=0.003). Eleven AGV eyes (20% of AGV failures) experienced persistent hypotony, explantation of implant, or loss of light perception compared to 22 (47% of failures) in the BGI group. The 5-year cumulative reoperation rate for glaucoma was 20.8% in the AGV group compared to 8.6% in the BGI group (p=0.010). Change in logMAR Snellen visual acuity (mean ± SD) at 5 years was 0.42 ± 0.99 in the AGV group and 0.43 ± 0.84 in the BGI group (p=0.97). Conclusions Similar rates of surgical success were observed with both implants at 5 years. BGI implantation produced greater IOP reduction and a lower rate of glaucoma reoperation than AGV implantation but BGI implantation was associated with twice as many failures due to safety issues such as persistent hypotony, loss of light perception, or explantation.

PURPOSE To compare the late complications in the Ahmed Baerveldt Comparison Study during 5 years of follow-up. DESIGN Multicenter, prospective, randomized clinical trial. METHODS SETTINGS Sixteen international clinical centers. STUDY POPULATION Two hundred seventy six subjects aged 18 to 85 years with previous intraocular surgery or refractory glaucoma with intraocular pressure of > 18 mmHg. INTERVENTIONS Ahmed Glaucoma Valve FP7 or Baerveldt Glaucoma Implant BG 101-350. MAIN OUTCOME MEASURES Late postoperative complications (beyond 3 months), reoperations for complications, and decreased vision from complications. RESULTS Late complications developed in 56 subjects (46.8 ± 4.8 5 year cumulative % ± SE) in the Ahmed Glaucoma Valve group and 67 (56.3 ± 4.7 5 year cumulative % ± SE) in the Baerveldt Glaucoma Implant group (P = 0.082). The cumulative rates of serious complications were 15.9% and 24.7% in the Ahmed Glaucoma Valve and Baerveldt Glaucoma Implant groups respectively (P = 0.034) although this was largely driven by subjects who had tube occlusions in the two groups (0.8% in the Ahmed Glaucoma Valve group and 5.7% in the Baerveldt Glaucoma Implant group, P = 0.037). Both groups had a relatively high incidence of persistent diplopia (12%) and corneal edema (20%), although half of the corneal edema cases were likely due to pre-existing causes other than the aqueous shunt. The incidence of tube erosion was 1% and 3% in the Ahmed Glaucoma Valve and Baerveldt Glaucoma Implant groups, respectively (P = 0.04). CONCLUSIONS Long term rates of vision threatening complications and complications resulting in reoperation were higher in the Baerveldt Glaucoma Implant than the Ahmed Glaucoma Valve group over 5 years of follow-up.

This 24-month multicenter randomized controlled trial demonstrated superior reduction in MDIOP and medication use among subjects with mild-to-moderate POAG who received a Schlemm canal microstent combined with phacoemulsification compared with phacoemulsification alone.

The 24-month results demonstrate that GATT is relatively safe and effective in treating various forms of open-angle glaucoma. The long-term results for GATT are relatively equivalent to those previously reported for GATT and ab externo trabeculotomy studies.