Tran 2005.

Study characteristics
Methods	Study design: randomized controlled trial Study grouping: within person Number randomly assigned: 18 eyes, 9 participants Exclusions after randomization: 1 eye, 1 participant Number analyzed: 14 eyes, 7 participants Unit of analysis: eye Losses to follow‐up: 0 reported Handling of missing data: not reported Power calculation: not reported Study dates: not reported
Participants	Country: USA Overall mean age: 37 years (SD 9.5) Age range: 23 to 50 years Gender: women 23%, men 77% Setting: private practice refractive surgery center, Irvine, CA Equivalence of baseline characteristics: yes Inclusion criteria: people with myopia or myopic astigmatism, visual acuity correctable to ≥ 20/40 in both eyes, stable refraction ≤ 4.00 D of spherical myopia, and no more than 2.00 D of refractive astigmatism in both eyes. Differences between fellow eyes had to be < 0.75 D in sphere and 0.50 D in cylinder. Exclusion criteria: residual, recurrent, or active ocular disease; previous ocular surgery; corneal topographic or pachymetry (or both) findings suspicious for keratoconus; and systemic autoimmune, connective tissue, or atopic disease
Interventions	Laser for ablation: Technolas 217A Intervention 1 Intervention: LASIK with a Hansatome microkeratome Flap dimensions: 160 μm thickness, 9.5 mm diameter, superior hinge Number of people randomized: 9 eyes, 9 participants Length of follow‐up: Planned: not reported Actual: 3 months Intervention 2 Intervention: LASIK with an IntraLase FS femtosecond laser Flap dimensions: 120 μm thickness, 8.8 mm diameter, and 45 degree superior hinged Number of people randomized: 9 eyes, 9 participants Length of follow‐up: Planned: not reported Actual: 3 months
Outcomes	Adverse events reported: yes Diffuse lamellar keratitis Intervals at which outcome assessed: 1 day; 1 week; 1 and 3 months Planned follow‐up: not reported Actual follow‐up: 3 months Scale: clinical grading scale Instrument for measurement: slit lamp examination Epithelial ingrowth Intervals at which outcome assessed: 1 day, 1 week 1, and 3 months Planned follow‐up: not reported Actual follow‐up: 3 months Scale: clinical grading scale Instrument for measurement: slit lamp examination
Identification	Sponsorship source: IntraLase Corp Country: USA Setting: private practice refractive surgery center Comments: none Author's name: Dan B Tran Institution: Coastal Vision Medical Group Email: dr.tran@coastallaservision Address: 709 East Anaheim Street, Long Beach, CA 90813, USA
Notes	Trial registration number: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Each eye of each patient was randomized to receive mechanical (Hansatome)." Comment: random component in the sequence generation not described
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	Low risk	Quote: "One eye of 1 patient was mildly amblyopic (BSCVA 20/25). The postoperative manifest refraction showed a high degree of variability in the amblyopic eye. This patient was dropped from the analysis."
Selective reporting (reporting bias)	Unclear risk	Comment: no published trial protocol with which to compare
Other bias	High risk	Quote: "Funded by IntraLase Corp., Irvine, California, USA. Drs. Tran, Sarayba, Bor, and Duh are paid consultants to IntraLase Corp, an industry directly related to one of the intervention groups evaluated.