Fea 2014.

Methods	Study design: parallel‐group RCT Unit of randomization: participant (1 eye per participant) Number randomized: 192 participants; 94 eyes of 94 participants in the iStent inject without combined phacoemulsification group and 98 eyes of 98 participants in the medical therapy group Unit of analysis: participant (1 eye per participant) Number analyzed: 192 participants; 94 eyes of 94 participants in the iStent inject without combined phacoemulsification and 98 eyes of 98 participants in the medical therapy group Exclusions and losses to follow‐up: unclear Handling of missing data: not reported
Participants	Country: Italy, Spain, Poland, Germany, the UK, and Armenia (multi‐centered) Age (mean ± SD): 64.5 ± 10.3 years in the iStent inject without combined phacoemulsification group; 64.3 ± 9.8 years in the medical therapy group Gender: 37 men and 57 women in the iStent inject without combined phacoemulsification group; 48 men and 50 women in the medical therapy Medicated IOP (mean ± SD): 21.1 ± 1.7 mmHg in the iStent inject without combined phacoemulsification group; 20.7 ± 1.7 mmHg in the medical therapy group Inclusion criteria: previous diagnosis of POAG age ≥ 18 years mean IOP ≥ 22 mmHg and < 38 mmHg (unmedicated) likely to be available able to give informed consent Exclusion criteria: known non‐responders to latanoprost secondary glaucoma prior incisional glaucoma surgery cloudy cornea signs of traumatic or uveitic, neovascular, or angle‐closure glaucoma Diagnoses in participants: POAG, PEXG, or PG
Interventions	Intervention 1: iStent inject without combined phacoemulsification Intervention 2: medical therapy, consisting of a fixed combination of latanoprost/timolol (Xalacom; Pfizer, New York, NY, USA) Length of follow‐up: 4 years
Outcomes	Primary outcome: mean IOP at 12 months Secondary outcomes: proportion of participants who achieved an IOP reduction ≥ 20% vs baseline unmedicated IOP; proportion of participants who achieved an IOP reduction ≤ 18 mmHg; mean change in IOP from baseline; proportion of participants who achieved an IOP reduction ≥ 30% vs baseline unmedicated IOP; proportion of participants who achieved an IOP reduction ≥ 40% vs baseline unmedicated IOP; proportion of participants who achieved an IOP reduction ≥ 50% vs baseline unmedicated IOP; and proportion of participants taking medication at 12 months Safety outcomes: vertical C:D ratio; eye burning; medication allergy; soreness/discomfort
Notes	Type of study: published Enrollment start year: 2009 Funding source: Glaukos Corporation, Laguna Hills, CA, USA provided study devices, sponsorship for performing this study, editorial assistance, and payment of article processing charges. Disclosures of interest: "The authors report no conflicts of interest in this work." Publication language: English Trial registration: NCT00913029
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Random sequence generation method not reported.
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not reported.
Blinding of outcome assessment (detection bias) Number of IOP‐lowering drops	High risk	Investigators describe a limitation of the study as "not a masked study due to the disparate forms of therapy."
Blinding of outcome assessment (detection bias) IOP measurement	High risk	Investigators describe a limitation of the study as "not a masked study due to the disparate forms of therapy."
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Completeness of outcome data varied between time points; some participants omitted from analysis at 1 time point returned at the next.
Selective reporting (reporting bias)	Low risk	Outcomes described in the results matched those specified in methods and in the ClinicalTrials.gov record.