Silicone Ahmed glaucoma valve with and without intravitreal triamcinolone acetonide for neovascular glaucoma: randomized clinical trial.

PURPOSE: To compare the effect on intraocular pressure (IOP) of the silicone Ahmed glaucoma valve with and without an intravitreal injection of triamcinolone acetonide. PATIENTS AND METHODS: Forty-nine patients with clinically uncontrolled neovascular glaucoma were included in the study; 22 were randomly assigned to the study group (silicone Ahmed glaucoma valve implant with intravitreal triamcinolone acetonide) and 27 to the control group (silicone Ahmed glaucoma valve). IOP was the primary outcome measure in this study. The secondary outcome measure was success, defined by IOP lower than 22 mm Hg and higher than 5 mm Hg, and no serious complications. Success rates in both the groups were compared using Kaplan-Meier survival curves and the log-rank test. IOP levels were compared using mixed linear model analysis to correct for repeated measures correlation.
RESULTS: Forty-three patients, 18 in the study group and 25 in the control group, completed the study (follow-up of 12 mo). The mean IOP was significantly lower after 1 year in both the groups (P<0.001). The mean IOP in the first month of follow-up was lower in the study group (control; 20.4±9.7, study; 13.6±6.5, P<0.01). The success rate at 1 year was 78% for the study group and 76% for the control group (P=0.82). Complication rates were not different between the groups.
CONCLUSIONS: Intravitreal injection of triamcinolone acetonide in neovascular glaucoma did not affect the intermediate-term success of the silicone Ahmed valve nor reduce the incidence of complications. The mean IOP spike in the first month was lower in the triamcinolone group.

RCT Entities:   Population Interventions Outcomes