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 |
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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 |
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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 |
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Outcomes |
Mean UCVA after surgery
Mean spherical equivalent of the refractive error after surgery
Proportion of eyes within ± 0.5 D of target refraction after surgery
Adverse events reported: no |
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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 |
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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: "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" |