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

Mingo‐Botin 2010.

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): 72 (44–90)

  • Sex (% men): not reported

  • Preoperative astigmatism: corneal: 1.73 (SD 0.59)

  • Preoperative astigmatism: refractive: –1.89 (SD 0.57)

  • Number of people (eyes): 20 (20)


LRI
  • Mean age in years (range): 76 (64–85)

  • Sex (% men): not reported

  • Preoperative astigmatism: corneal: 1.82 (SD 0.53)

  • Preoperative astigmatism: refractive: –2.17 (SD 1.03)

  • Number of people (eyes): 20 (20)


Overall
  • Mean age in years (range): 74 (44–90)

  • Sex (% men): not reported

  • Preoperative astigmatism: corneal: 1.78 (SD not reported)

  • Preoperative astigmatism: refractive: –2.03 (SD not reported)

  • Number of people (eyes): 40 (40)


Inclusion criteria: visually significant cataract, regular corneal astigmatism 1.00–3.00 D, and pharmacological mydriasis ≥ 6.0 mm to allow intraoperative and postoperative visualisation of axis marks on the toric IOL.
Exclusion criteria: previous surgery in the eye under study, ocular disease that would lead to poor postoperative corrected visual acuity (corneal scarring, uveitis, advanced glaucoma, neuro‐ophthalmic disease, significant macular disease or other retinopathy), zonule or pupil abnormalities, and irregular astigmatism or astigmatism outside the defined range.
Pretreatment differences: LRI group slightly older.
Interventions Intervention characteristics
Toric IOLs
  • Type of IOL: toric IOL (AcrySof Toric, Alcon, Inc.)


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

  • Incision technique: in the relaxing incisions group, PCRIs were created inside the limbus using a calibrated diamond knife with the blade depth 600 μm. In eyes with against‐the‐rule astigmatism, the main incision for phacoemulsification was created to match the location of the LRI. At the end of surgery, the PCRIs were performed including the previous incision, and a paired incision was made on the opposite side. In eyes with with‐the‐rule astigmatism, both PCRIs were created on the steep axis before the globe was entered at the beginning of the procedure. Size and location of PCRIs according to the Nichamin nomogram recorded.

Outcomes Uncorrected distance visual acuity, corrected distance visual acuity, intraocular pressure, refraction, keratometry, corneal topography, contrast sensitivity with/without glare, participant satisfaction, quality of  life (VF‐14)
Adverse effects: intraoperative complications
Follow‐up: 1 day, 1 and 3 months
Identification Sponsorship source: not reported
Country: Spain
Authors name: David Mingo‐Botin
Email: davimnbot@gmail.com
Conflict of interest: none
Date study conducted: May 2008 to June 2009
Trial registration ID: not reported
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The patients were randomly assigned to receive a toric IOL (AcrySof Toric, Alcon, Inc.) or a spherical IOL (AcrySof Natural, Alcon, Inc.) associated with peripheral corneal relaxing incisions."
Judgement comment: insufficient information to judge.
Allocation concealment (selection bias) Unclear risk Judgement comment: insufficient information to judge. We contacted study authors for clarification but received no response.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Judgement comment: insufficient information to judge. We contacted study authors for clarification but received no response.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Judgement comment: insufficient information to judge. 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.