Leon 2015.

Methods	Study design: randomised controlled trial Study grouping: parallel group Eyes/people: 1 eye per person (study eye); unclear how this study eye was selected.
Participants	Baseline characteristics Toric IOLs Mean age in years (range): 70 (53–85) Sex (% men): 50% Preoperative astigmatism: corneal: 1.32 (SD 0.55) Preoperative astigmatism: refractive: 1.59 (SD 0.52) Number of people (eyes): 52 (52) LRI Mean age in years (range): 71 (62–88) Sex (% men): 44% Preoperative astigmatism: corneal: 1.27 (SD 0.58) Preoperative astigmatism: refractive: 1.91 (SD 0.63) Number of people (eyes): 50 (50) Overall Mean age in years (range): 70 (53–88) Sex (% men): 47% Preoperative astigmatism: corneal: 1.30 (SD not reported) Preoperative astigmatism: refractive: 1.75 (SD not reported) Number of people (eyes): 102 (102) Inclusion criteria: significant cataract (II–IV group LOCS III), regular corneal astigmatism (1.0–2.0 D), with‐the‐rule astigmatism, mean axial length 23–24 mm, regular and symmetric astigmatism shape at the corneal topographic map, regular and with‐the‐rule astigmatism of the posterior corneal surface, pharmacologic mydriasis > 6.00 mm diameter to allow intraoperative and postoperative visualisation of axis marks on the toric IOLs. Exclusion criteria: previous surgery in the eye under study, irregular astigmatisms of the anterior or the posterior corneal surfaces, against‐the‐rule astigmatism, ocular diseases (pupil or zonular abnormalities, corneal scaring, uveitis, glaucoma, neuro‐ophthalmic diseases, significant macular disease or other retinopathy). Pretreatment differences: none
Interventions	Intervention characteristics Toric IOLs Type of IOL: AcrySof IQ Toric IOL (Alcon Inc.) LRI Type of IOL: monofocal AcrySof IQ Aspheric IOL (Alcon Inc.) Incision technique: size and location of LRI according to the Nichamin nomogram. Based on the procedure described by Langerman, a vertical limbal relaxing wound was created with a guarded micrometre diamond blade by making a groove concentric to the limbus. Incision depth set at 600 μm equal to approximately 85% of the peripheral corneal thickness at the axis to be cut and the incisions were approximately 3 mm. After the paired incision was made, the penetrating CCI was made along the steepest axis in the upper area for the cataract surgery, along the same axis as the LRI.
Outcomes	Uncorrected distance visual acuity, best‐corrected distance visual acuity, topographic and keratometric changes in cornea, refractive evaluation and residual astigmatism, lens misalignment, endothelial cell count Adverse effects: not reported Follow‐up: 1, 3 and 6 months
Identification	Sponsorship source: not reported Country: Italy Authors name: Pia Leon Email: pialeon@libero.it Conflict of interest: none Date study conducted: January 2013 to June 2013 Trial registration ID: not reported
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients were randomly assigned to one of the two treatments computer. A randomized number was assigned to each patient when the inclusion and exclusion criteria were satisfied."
Allocation concealment (selection bias)	Low risk	Quote: "Patients were randomly assigned to one of the two treatments computer. A randomized number was assigned to each patient when the inclusion and exclusion criteria were satisfied." Judgement comment: as the random allocation done after inclusion, implication is that the allocation was concealed.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Judgement comment: not reported. We contacted study authors for clarification but received no response.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Judgement comment: not reported. We contacted study authors for clarification but received no response.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Judgement comment: not reported. We contacted study authors for clarification but received no response.
Selective reporting (reporting bias)	Unclear risk	Judgement comment: insufficient information to judge. We contacted study authors for clarification but received no response.