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

Salomão 2009.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: within person
Number randomly assigned: 183 eyes, 183 participants
Exclusions after randomization: 0
Number analyzed: 183 eyes, 183 participants
Unit of analysis: eye
Losses to follow‐up: 0
Handling of missing data: no missing data
Power calculation: not reported
Study dates: 2005 to 2007
Participants Country: USA
Overall mean age: 44 years (SD not reported)
Age range: 20 to 72 years
Gender: women 53.5%, men 46.5%
Setting: Cole Eye Institute, Cleveland, OH
Equivalence of baseline characteristics: yes
Inclusion criteria: people with low‐to‐moderate myopia with no symptoms or signs of dry eye before LASIK
Exclusion criteria: previous eye surgery, topical ocular medications before surgery, and other ocular conditions, such as ocular rosacea or chronic blepharitis
Interventions Laser for ablation: Visx Star S4 IR or LADARWave 600
Intervention 1
Intervention: LASIK with a Hansatome microkeratome
Flap dimensions: 180 μm thickness, 9.5 mm diameter, superior hinge
Number of people randomized: 70 eyes, 70 participants
Length of follow‐up:
Planned: not reported
Actual: 9 months
Intervention 2
Intervention: LASIK with an IntraLase FS femtosecond laser
Flap dimensions: 100 μm to 110 μm thickness, 9.0 mm to 9.3 mm diameter, and superior hinge
Number of people randomized: 113 eyes, 113 participants
Length of follow‐up:
Planned: not reported
Actual: 9 months
Outcomes Adverse events reported: yes
Dry eye
  • Intervals at which outcome assessed: 1 day; 1 week; 1, 3, and 9 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 9 months

  • Scale: clinical grading scale

  • Instrument for measurement: slit lamp examination

Identification Sponsorship source: United States Public Health Service grants EY010056 and EY015638 from the National Eye Institute, Bethesda, Maryland, and Research to Prevent Blindness, New York, NY, USA
Country: USA
Setting: Institute of Ophthalmology
Comments: none
Author's name: Steven E Wilson
Institution: Cole Eye Institute, I‐32, Cleveland Clinic
Email: wilsons4@ccf.org
Address: 9500 Euclid Avenue, Cleveland, OH 44195
Notes Trial registration number: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "One eye of each patient was randomly chosen for inclusion in the trial."
Comment: random component in the sequence generation not described
Allocation concealment (selection bias) Unclear risk Comment: trial did not address this risk of bias
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Comment: trial did not address this risk of bias
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Comment: trial did not address this risk of bias
Incomplete outcome data (attrition bias)
All outcomes Low 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