3.1 To inform the committee, NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 5 sources, which was discussed by the committee. The evidence included 1 randomised controlled trial and 4 case series, and is presented in table 2 of the interventional procedure overview. Other relevant literature is in the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: reduction in intraocular pressure that persists long-term, reduction in glaucoma medications, and quality of life.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: hypotony and loss of vision.
3.4 Patient commentary was sought but none was received.
3.5 The committee noted that the evidence they reviewed was based on a single device.
3.6 The committee noted that the procedure can be done with or without concomitant cataract surgery, but this guidance only covers the use of this procedure with phacoemulsification.