A prospective randomized controlled study of Aurolab aqueous drainage implant versus Ahmed glaucoma valve in refractory glaucoma: A pilot study.

Abstract

Purpose:To study the efficacy of the Aurolab aqueous drainage implant (AADI) compared to Ahmed glaucoma valve (AGV) in patients with refractory glaucoma.Methods:This was a prospective, randomized controlled trial. Thirty-eight adult patients (>18 years) scheduled for a glaucoma drainage device (GDD) were randomized into two groups to receive either AGV or AADI. Primary outcome measures: intraocular pressure (IOP) control and requirement of antiglaucoma medications; secondary outcome measures: final best correct visual acuity (log MAR), visual field (Visual field index [VFI], mean deviation [MD] and pattern standard deviation [PSD]), postoperative complications and additional interventions. Complete success was defined as IOP ≥5–≤18 mmHg without antiglaucoma medications/laser/additional glaucoma surgery or any vision threatening complications.Results:There were 19 age and sex-matched patients in each group. Both groups had comparable IOP before surgery (P = 0.61). The AGV group had significantly lower IOP compared to AADI group (7.05 ± 4.22 mmHg vs 17.90 ± 10.32 mmHg, P = <0.001) at 1 week. The mean postoperative IOP at 6 months was not significantly different in the two groups (13.3 ± 4.2 and 11.4 ± 6.8 mmHg respectively; P = 0.48). At 6 months, complete success rate according to antiglaucoma medication criteria was 78.94% in AADI and 47.36% in AGV groups. AGV group required 1.83 times more number of topical medications than AADI group. There was no significant difference in early (P = 0.75) and late (P = 0.71) postoperative complications in the AADI and AGV group. The complete success rate was higher in AADI group (68.42%) than AGV group (26.31%) (P = 0.034).Conclusion:In this study, AADI appears to have comparable efficacy versus AGV implant with higher complete success rate at 6 months follow-up.