Freitas 2014.
Methods |
Study design: randomised controlled trial Study grouping: parallel group Eyes/people: people randomly allocated to treatment, both eyes included in study. Analysis probably not adjusted for within‐person correlation. |
|
Participants |
Baseline characteristics Toric IOLs
LRI
Overall
Inclusion criteria: aged > 40 years; visually significant cataract, defined as spectacle distance corrected visual acuity (SDCVA) worse than Snellen 20/40 (LogMAR scale of 0.3); regular corneal astigmatism ranging 0.75–2.50 D; pharmacological mydriasis ≥ 6.0 mm (measured at the slit lamp) to facilitate proper intraoperative visualisation of axis marks on surface of the toric IOL. Exclusion criteria: history of previous surgery, pterygium, ocular disease that would lead to poor postoperative corrected visual acuity (corneal scarring, uveitis, advanced glaucoma, neuro‐ophthalmic disease, and significant macular disease or other retinopathy), or zonule or pupil abnormalities. Pretreatment differences: LRI group older (mean age: 66 years in IOL group vs 72 years in LRI group). |
|
Interventions |
Intervention characteristics Toric IOLs
LRI
|
|
Outcomes | Manifest refraction, uncorrected distance visual acuity and spectacle distance corrected visual acuity, spherical equivalent refraction
Adverse effects: persistent corneal oedema, pupillary block, retinal detachment, endophthalmitis Follow‐up: 1, 3 and 6 months after surgery |
|
Identification |
Sponsorship source: financial contributors: private: Alcon Labs. Brazil Sao Paulo (SP), provided all IOLs at no cost for scientific purposes. Public: Municipal Health Authority of Uberlândia funded surgical procedures as part of a regular governmental assistance policy. Country: Brazil Authors name: Giuliano Oliveira Freitas Email: gofreitas@ufmg.br Conflict of interest: none Trial registration ID: not reported Date study conducted: May 2010 to June 2012 |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomly assigned using the Microsoft Excel TM “=RANDBETWEEN(1;2)”" |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: information not provided. We contacted study authors for clarification but received no response. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Judgement comment: no statement of any blinding of participant or surgeon in the text. Information not provided. We contacted study authors for clarification but received no response. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judgement comment: no statement of blinding of the examiner. We contacted study authors for clarification but received no response. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "All patients completed the follow‐up period of 6 months." |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no obvious selective outcome reporting from methods but difficult to judge because no access to protocol or trial registration record (or both). We contacted study authors for clarification but received no response. |