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. 2020 Apr 7;2020(4):CD012946. doi: 10.1002/14651858.CD012946.pub2

Zhou 2012.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: parallel group
Number randomly assigned: 720 eyes, 360 participants
Exclusions after randomization:
Number analyzed: 720 eyes, 360 participants
Unit of analysis: eye
Losses to follow‐up: not reported
Handling of missing data: not reported
Power calculation: not reported
Study dates: December 2009 to July 2010
Participants Country: China
Overall mean age: 25.91 years (SD 5.03)
Age range: not reported
Gender: not reported
Setting: Ophthalmic Center, Beijing Tongren Hospital, Capital Medical University
Equivalence of baseline characteristics: yes
Inclusion criteria: not reported
Exclusion criteria: patients with ocular pathologies such as keratoconus, corneal scars, corneal dystrophies, previous ocular surgery, glaucoma, diabetes, or other systemic diseases known to affect the eye were excluded
Interventions Laser for ablation: Visx S4 excimer laser
Intervention 1
Intervention: LASIK with a M2 Moria Microkeratome
Flap dimensions: 110 μm thickness, 8.5 mm diameter, superior hinge
Number of people randomized: 360 eyes, 180 participants
Length of follow‐up:
Planned: not reported
Actual: 1 week
Intervention 2
Intervention: LASIK with an Ziemer LDV femtosecond laser
Flap dimensions: 110 μm thickness, 8.5 mm diameter, superior hinge
Number of people randomized: 360 eyes, 180 participants
Length of follow‐up:
Planned: not reported
Actual: 1 week
Outcomes Central corneal flap thickness
  • Intervals at which outcome assessed: 1 day, 3 days, and 1 week.

  • Planned follow‐up: not reported

  • Actual follow‐up: 1 week

  • Scale: μm

  • Instrument for measurement: RTVue OCT system


Mean corneal flap thickness
  • Intervals at which outcome assessed: 1 day, 3 days, and 1 week.

  • Planned follow‐up: not reported

  • Actual follow‐up: 1 week

  • Scale: μm

  • Instrument for measurement: RTVue OCT system


Nasal and temporal flap thickness
  • Intervals at which outcome assessed: 1 day, 3 days, and 1 week.

  • Planned follow‐up: not reported

  • Actual follow‐up: 1 week

  • Scale: μm

  • Instrument for measurement: RTVue OCT system


Flap dimensions and regularity
  • Intervals at which outcome assessed: 1 day, 3 days, and 1 week.

  • Planned follow‐up: not reported

  • Actual follow‐up: 1 week

  • Scale: μm

  • Instrument for measurement: RTVue OCT system


Flap thickness accuracy
  • Intervals at which outcome assessed: 1 day, 3 days, and 1 week.

  • Planned follow‐up: not reported

  • Actual follow‐up: 1 week

  • Scale: μm

  • Instrument for measurement: RTVue OCT system

Identification Sponsorship source: not reported
Country: China
Setting: Institute of Ophthalmology
Comments: none
Author's name: Yuehua Zhou
Institution: Ophthalmic Center, Beijing Tongren Hospital
Email: yh0220@yahoo.com
Address: No. 1 Dongjiaomin Ln, Dongchong District, Beijing, China 100730
Notes Trial registration number: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Based on a randomization table, 180 patients were assigned to the Ziemer LDV (FS laser group) and 180 patients were assigned to the Moria M2 (microkeratome group) for bilateral LASIK"
Allocation concealment (selection bias) Unclear risk Comment: method of concealment not described
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Comment: masking of participants and trial personnel not reported
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Comment: masking of outcome assessors not reported
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Comment: no missing outcome data
Selective reporting (reporting bias) Unclear risk Comment: no published trial protocol with which to compare
Other bias Low risk Comment: trial appeared free of other sources of bias

BCVA: best corrected visual acuity; D: diopter; IOP: intraocular pressure; LASIK: laser‐assisted in‐situ keratomileusis; SD: standard deviation; UCVA: uncorrected visual acuity.