3.1 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 9 sources, which was discussed by the committee. The evidence included 1 non-randomised comparative study, 7 case series and 1 case report. It is presented in table 2a of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: reduction in symptoms of glare, improvement in visual acuity, quality of life and other patient-reported outcomes.
3.3 The professional experts and the committee considered the key safety outcomes to be: need for explantation, infection, worsening visual acuity, glaucoma and implant displacement.
3.4 One submission from a patient organisation was discussed by the committee.
3.5 Patient commentary was sought but none was received.
3.6 There is more than 1 device available for this procedure, including a flexible implant and a solid implant.
3.7 The committee was informed that at least 1 of the devices should only be used when the natural lens has been removed.
3.8 The committee noted that there was little evidence on the use of the procedure in children.