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 |
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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 |
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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 |
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Outcomes | Central corneal flap thickness
Mean corneal flap thickness
Nasal and temporal flap thickness
Flap dimensions and regularity
Flap thickness accuracy
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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 |
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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.