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

Titiyal 2014.

Methods Study design: randomised controlled trial
Study grouping: parallel group
Eyes/people: 1 eye per person included in the study (study eye); unclear how this study eye was selected.
Participants Baseline characteristics
Toric IOLs
  • Mean age in years (range): 61 (not reported)

  • Sex (% men): not reported

  • Preoperative astigmatism: corneal: 2.02 (SD 0.53)

  • Preoperative astigmatism: refractive: 2.00 (SD 0.49)

  • Number of people (eyes): 17 (17)


LRI
  • Mean age in years (range): 62 (not reported)

  • Sex (% men): not reported

  • Preoperative astigmatism: corneal: 2.18 (SD 0.59)

  • Preoperative astigmatism: refractive: 1.95 (SD 0.47)

  • Number of people (eyes): 17 (17)


Overall
  • Mean age in years (range): 61 (not reported)

  • Sex (% men): not reported

  • Preoperative astigmatism: corneal: 2.10 (SD not reported)

  • Preoperative astigmatism: refractive: 1.98 (SD not reported)

  • Number of people (eyes): 34 (34)


Inclusion criteria: aged 45–65 years, presented to the outpatient department or anterior segment services of the centre with visually significant immature senile cataract, regular bow‐tie moderate corneal astigmatism (1.25–3.0 D) and no ocular or systemic contraindications to surgery.
Exclusion criteria: complicated cataract, posterior segment pathology, astigmatism < 1.25 D or > 3.00 D, systemic condition likely to result in an unpredictable response to surgery (e.g. collagen vascular disease, diabetes mellitus), inability to attend follow‐up visits or who were not willing to provide written consent.
Pretreatment differences: no obvious group differences
Interventions Intervention characteristics
Toric IOLs
  • Type of IOL: toric IOL (AcrySof IQ Toric, Alcon Surgical, Inc.)


LRI
  • Type of IOL: aspheric IOL (AcrySof IQ, Alcon Surgical, Inc.)

  • Incision technique: a 12‐blade radial keratotomy marker was placed on the 7.0 mm optical zone mark. Paired arcuate keratotomy incisions were made in the 7.0 mm optical zone. The 30‐degree paired AK cuts were made on the steeper meridian using a micrometer‐guided diamond knife (Meyco) that was set at 100% of the thinnest paracentral pachymetry.

Outcomes Uncorrected distance visual acuity, corrected distance visual acuity, corneal topography, endothelial cell density, subjective refraction and manual keratometry, residual astigmatism (vector analysis)
Adverse effects: IOL alignment, corneal ectasia, hyperopic shift
Follow‐up: 1 day, 1 week, 1 and 3 months
Identification Sponsorship source: not reported
Country: India
Authors name: Namrata Sharma
Email: namrata.sharma@gmail.com
Conflict of interest: none
Date study conducted: not reported
Trial registration ID: not reported
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients who met the inclusion criteria were recruited and randomized into 2 groups with an equal number of eyes. Randomization was performed using a table of random numbers."
Allocation concealment (selection bias) Unclear risk Judgement comment: not reported. We contacted study authors for clarification but received no response.
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 Low risk Quote: "The study enrolled 34 eyes of 34 patients; each of the 2 groups comprised 17 eyes. There were no dropouts in either group, and all patients were followed regularly for a minimum of 3 months."
Selective reporting (reporting bias) Unclear risk Judgement comment: insufficient information to judge. We contacted study authors for clarification but received no response.

BCVA: best corrected visual acuity; CCI: clear corneal incision; ETDRS: Early Treatment Diabetic Retinopathy Study; IOL: intraocular lens; LOCS: Lens Opacities Classification System; LRI: limbal relaxing incision; PCRI: peripheral corneal relaxing incision; SD: standard deviation; SIA: surgically induced astigmatism; VF‐14: Visual Function Index.