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. 2019 Dec 17;2019(12):CD012801. doi: 10.1002/14651858.CD012801.pub2

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
  • Mean age in years (range): 66 (52–80)

  • Sex (% men): 27%

  • Preoperative astigmatism: corneal: 1.41 (0.80–2.5)

  • Preoperative astigmatism: refractive: not reported

  • Number of people (eyes): 15 (30)


LRI
  • Mean age in years (range): 72 (51–84)

  • Sex (% men): 50%

  • Preoperative astigmatism: corneal: 1.32 (0.75–2.4)

  • Preoperative astigmatism: refractive: not reported

  • Number of people (eyes): 16 (32)


Overall
  • Mean age in years (range): 69 (51–84)

  • Sex (% men): 39%

  • Preoperative astigmatism: corneal: 1.36 (0.75–2.50)

  • Preoperative astigmatism: refractive: not reported

  • Number of people (eyes): 31 (62)


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
  • Type of IOL: AcrySof Toric, Alcon, Inc.


LRI
  • Type of IOL: AcrySof Natural, Alcon, Inc.

  • Incision technique: LRIs placed inside limbus using a calibrated diamond knife with a preset blade depth of 600 μm. Size and location of LRIs determined via an online open source application (www.lricalculator.com), according to the Donnenfeld nomogram.

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.