Fernández‐Barrientos 2010.

Methods	Study design: parallel‐group RCT Unit of randomization: the individual (one eye per participant) Number randomized: 33 total; 17 eyes of 17 participants in combined surgery group and 16 eyes of 16 participants in cataract surgery alone group Unit of analysis: the individual (one eye per participant) Number analyzed: 33 total; 17 eyes of 17 participants in combined surgery group and 16 eyes of 16 participants in cataract surgery alone group Exclusions and losses to follow‐up: none for IOP study Power calculation: sample size of 12 eyes in each group needed for 80% power to detect a 0.3 µL/min/mmHg difference in the outflow facility
Participants	Country: Madrid, Spain (3 sites) Age (mean ± SD): 75.2 ± 7.2 years (range: 63 to 86) in combined surgery group; 76.7 ± 5.8 years (range: 64 to 89) in cataract surgery alone group Gender: 6 men and 11 women in combined surgery group; 9 men and 7 women in cataract surgery alone group Ethnicity: not reported Inclusion criteria: 18 years of age or older cataract that requires surgery IOP > 17 and < 31 mmHg with treatment and > 21 and < 36 mmHg after the pharmacologic washout period minimum visual acuity of 20/200 or better authorization and signature of informed consent Exclusion criteria: closed‐angle glaucoma secondary glaucoma, non‐neovascular, uveitic, or angular recession glaucoma glaucoma due to vascular disorder glaucoma due to burns with chemical elements peripheral anterior synechiae in the area where the implant is inserted cornea with opacity that impedes gonioscopy vision from the nasal angle, or scleral spur not clearly visible, or both previous glaucoma procedures (e.g., trabeculectomy, viscocanalostomy, argon laser trabeculoplasty, selective laser trabeculoplasty, drainage implant, collagen implant, cyclodestruction procedure) previous refractive surgery that makes IOP measures difficult ocular surface disorders chronic inflammatory disease previous ocular trauma retrobulbar tumor Sturge‐Weber syndrome thyroid ocular illness elevated episcleral venous pressure due to a history of thyroid orbitopathy, carotid cavernous fistula, orbital tumor, or congestive orbital illness threat of visual field fixation Equivalence of baseline characteristics: yes (age, sex, stage of glaucoma) Diagnoses in participants: open‐angle glaucoma or ocular hypertension and cataract
Interventions	Intervention 1: combined cataract surgery (phacoemulsification) and 2 iStent® implantations Intervention 2: cataract surgery (phacoemulsification) alone Study follow‐up: 12 months
Outcomes	Primary outcomes: aqueous flow and trabecular outflow facility Secondary outcomes: mean IOP number of glaucoma medications change in anterior chamber complications Adverse events reported: no Intervals at which outcomes assessed: 1, 2 and 7 to 14 days, and 1, 3, 6, and 12 months after surgery
Notes	Type of study: published Study period: January to June 2006 enrolment Funding source: supported by Glaukos Corporation Disclosures of interest: authors reported receiving financial support, consulting, and/or being the recipient of gifts from the Glaukos Corporation 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
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not reported
Masking (detection bias)	Low risk	"All postoperative evaluations… were performed by the same examiner (YFB), who was masked to the type of surgery performed"
Incomplete outcome data (attrition bias) All outcomes	Low risk	No incomplete outcome data for IOP and participants analyzed by group to which they were randomized
Selective reporting (reporting bias)	Low risk	Results for outcomes described in Methods section of study publication reported
Other bias	Unclear risk	Industry support and all authors affiliated with industry