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

Durrie 2005.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: within person
Number randomly assigned: 102 eyes, 51 participants
Exclusions after randomization: 0
Number analyzed: 102 eyes, 51 participants
Unit of analysis: eye
Losses to follow‐up: 0
Handling of missing data: no missing data
Power calculation: not reported
Study dates: July 2003 to August 2003
Participants Country: USA
Overall mean age: 34.7 years (SD 7.7)
Age range: not reported
Gender: women 69%, men 31%
Setting: not reported
Equivalence of baseline characteristics: yes
Inclusion criteria: people with a manifest myopic refractive error up to 7.00 D sphere with < 0.50 D astigmatism in both eyes or aberrometer dilated refraction up to 7.50 D sphere with < 1.50 D astigmatism, age ≥ 21 years, a normal ophthalmic examination except for refractive error, normal topography, no history of ocular surgery, stable refraction within 60.50 D over the past year, no ongoing use of ophthalmic or systemic medications, and no history of autoimmune disease
Exclusion criteria: not reported
Interventions Laser for ablation: LADARVision 4000
Intervention 1
Intervention: LASIK with a Hansatome microkeratome
Flap dimensions: 180 μm thickness, 9.5 mm diameter, superior hinge
Number of people randomized: 51 eyes, 51 participants
Length of follow‐up:
Planned: not reported
Actual: 3 months
Intervention 2
Intervention: LASIK with an IntraLase femtosecond laser
Flap dimensions: 118 μm thickness, 9.5 mm diameter, and 55 degree superior hinge
Number of people randomized: 51 eyes, 51 participants
Length of follow‐up:
Planned: not reported
Actual: 3 months
Outcomes Mean UCVA after surgery
  • Intervals at which outcome assessed: 1 day, 1 week, and 1 and 3 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 3 months

  • Scale: logMAR

  • Instrument for measurement: Electronic Early Treatment of Diabetic Retinopathy trial testing protocol


Mean spherical equivalent of the refractive error after surgery
  • Intervals at which outcome assessed: 1 day, 1 week, and 1 month

  • Planned follow‐up: not reported

  • Actual follow‐up: 3 months

  • Scale: D

  • Instrument for measurement: not reported


Proportion of eyes within ± 0.5 D of target refraction after surgery
  • Intervals at which outcome assessed: 1 day, 1 week, and 1 and 3 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 3 months

  • Scale: D

  • Instrument for measurement: not reported


Adverse events reported: no
Identification Sponsorship source: not reported
Country: USA
Setting: Institute of Ophthalmology
Comments: none
Author's name: Guy M Kezirian
Institution: SurgiVision Consultants, Inc.
Email: guy1000@surgivision.net
Address: 2183 Hathaway Avenue, Westlake Village, CA 91362‐5170
Notes Trial registration number: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The selection of the flap creation method was done at the time of enrollment using a predefined randomization schedule."
Allocation concealment (selection bias) Unclear risk Comment: method of concealment not described
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 Low risk Quote: "Clinical examinations were performed by optometrists trained in LASIK evaluations who were blinded to which eye had the femtosecond laser flap."
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "All patients (51/51, 100%) appeared for the 1‐ and 3‐month visits."
Selective reporting (reporting bias) Unclear risk Comment: no published trial protocol with which to compare
Other bias High risk Quote: "Dr. Durrie is a paid consultant to IntraLase Corporation and Alcon Laboratories, Inc. Dr. Kezirian received financial compensation from IntraLase Corporation for his assistance with data analysis and preparation of the manuscript"