Fea 2010.

Methods	Study design: parallel‐group RCT Unit of randomization: the individual (one eye per participant) Number randomized: 36 total; 12 eyes of 12 participants in combined surgery group and 24 eyes of 24 participants in cataract surgery alone group Unit of analysis: the individual (one eye per participant) Number analyzed: 33 total; 12 eyes of 12 participants in combined surgery group and 21 eyes of 21 participants in cataract surgery alone group Exclusions and losses to follow‐up: 3 participants in the cataract surgery alone group: 1 capsule rupture, 1 did not present for the 6 months follow‐up, 1 died Power calculation: sample size of 12 eyes in combined surgery group and 24 eyes in cataract surgery alone group needed for 80% power to detect a difference in IOP of around 3 mmHg between the two intervention groups
Participants	Country: Torino, Italy (single site) Age (mean ± SD): 64.5 ± 3.4 years (range: 60 to 70) in combined surgery group; 64.9 ± 3.1 years (range: 59 to 71) in cataract surgery alone group Gender: 4 men and 8 women in combined surgery group; 9 men and 15 women in the cataract surgery alone group Ethnicity: not reported Inclusion criteria: previous diagnosis of POAG IOP above 18 mmHg at three separate visits on 1 or more ocular hypotensive medications preoperative corrected distance visual acuity no better than 0.6 (20/80) likely to follow surgeon instructions ability to give informed consent Exclusion criteria: glaucoma diagnosis other than POAG (i.e., Scheie grade < 2) peripheral anterior synechiae cloudy cornea likely to inhibit gonioscopic view of the angle previous ocular surgery (including glaucoma‐filtering surgery) history of trauma or ocular surface disease history of preproliferative or proliferative diabetic retinopathy age‐related macular degeneration with macular scar or large macular atrophy that would inhibit potential visual acuity Equivalence of baseline characteristics: yes (IOP, number of glaucoma medications) Diagnoses in participants: POAG and cataract
Interventions	Intervention 1: combined cataract surgery (phacoemulsification) with IOL implantation and iStent® implantation Intervention 2: cataract surgery (phacoemulsification) with IOL implantation alone Study follow‐up: 15 months
Outcomes	Primary outcome: mean IOP Secondary outcomes: number and type of glaucoma medications Adverse events reported: no Intervals at which outcomes assessed: 24 hours, 1 week, and 1, 2, 3, 6, 9, 12, and 15 months after surgery
Notes	Type of study: published Study period: not reported Funding source: study devices provided by Glaukos Corp., Laguna Hills, California, USA; supported by Ricerca Finalizzata Della Regione Piemonte 2007 Disclosures of interest: "The author has no financial or proprietary interest in any material or method mentioned." Publication language: English Subgroup analysis: none reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer random number generator used: "Patient randomization was generated with a 2:1 ratio using Stata data analysis and statistical software"
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not reported
Masking (detection bias)	Low risk	"Patients were masked to their assignment, as were staff members who measured IOP throughout the study"
Incomplete outcome data (attrition bias) All outcomes	High risk	3 of 36 (8%) participants excluded from final analysis: all in cataract surgery alone group (12%)
Selective reporting (reporting bias)	Low risk	Results for outcomes described in Methods section of study publication reported
Other bias	Unclear risk	Study devices provided by device manufacturer