The Singapore Asymptomatic Narrow Angles Laser Iridotomy Study (ANA-LIS): 5 year results of a Randomized Controlled Trial.

PURPOSE To examine the efficacy of laser peripheral iridotomy (LPI) in subjects diagnosed as primary angle closure suspects (PACS) DESIGN: Prospective, randomized controlled trial PARTICIPANTS: This multi-center, randomized controlled trial (NCT00347178, Clinical trials.gov) enrolled 480 subjects over the age of 50 years from glaucoma clinics in Singapore with bilateral asymptomatic PACS (defined as having ≥2 quadrants of appositional angle closure on gonioscopy). METHODS Each subject underwent prophylactic LPI in one randomly selected eye, while the fellow eye served as control. Subjects were followed up yearly for 5 years. MAIN OUTCOME MEASURES The primary outcome measure was development of primary angle closure (PAC, defined as presence of peripheral anterior synechiae, and/or intraocular pressure>21 mmHg or acute angle closure [AAC]) or PACG over 5 years. RESULTS Of the 480 randomized subjects, the majority were Chinese (92.7%) and female (75.8%) with mean age of 62.8±6.9 years. LPI-treated eyes reached endpoint less frequently after five years (24, 5.0%, incidence rate [IR]=11.65 per 1000 eye-years) compared to control eyes (45, 9.4%, IR=21.84 per 1000 eye-years, p=0.001). The adjusted hazards ratio (HR) for progression to PAC was 0.55 (95%CI: 0.37-0.83, p=0.004) in LPI-treated eyes compared to control eyes. Older subjects (per year, HR=1.06, 95%CI: 1.03-1.10, p<0.001) and eyes with higher baseline IOP (per mm Hg, HR=1.35, 95%CI: 1.22-1.50, p<0.0001) were more likely to reach an endpoint. The number needed to treat in order to prevent an endpoint was 22 (95%CI: 12.8-57.5). CONCLUSIONS In subjects with bilateral asymptomatic PACS, eyes that underwent prophylactic LPI had significantly fewer endpoints compared to control eyes over 5 years. However, the overall incidence of PAC or PACG was low.