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 4 sources, which was discussed by the committee. The evidence included 2 systematic reviews and meta-analyses, 1 randomised controlled trial, and 1 case report. It is presented in the summary of key evidence section in the overview. Other relevant literature is in the appendix of the overview.
The professional experts and the committee considered the key efficacy outcomes to be: reduction in intraocular pressure, reduction in medication use, preservation of visual fields, and quality of life.
The professional experts and the committee considered the key safety outcomes to be: hypotony, pain, bleeding and infection.
Patient commentary was sought but none was received.
The committee was informed that the biodegradable collagen matrix implant is made from porcine collagen.
The committee noted that a potential advantage of this procedure is that it avoids the use of mitomycin C as an adjunct to trabeculectomy, which can cause postoperative side effects such as thinning of the conjunctiva and bleb leaks.
The committee noted that most of the evidence was from adults with open-angle glaucoma, and that the safety of the device has not been established in pregnancy, or in babies or children.