Skip to main content
. 2020 Apr 7;2020(4):CD012946. doi: 10.1002/14651858.CD012946.pub2

Hasimoto 2013.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: within person
Number randomly assigned: 38 eyes, 19 participants
Exclusions after randomization: 6 eyes, 3 participants
Number analyzed: 32 eyes, 16 participants
Unit of analysis: eye
Losses to follow‐up: 0
Handling of missing data: eyes with missing data excluded from analysis
Power calculation: not reported
Study dates: July 2010 to September 2010
Participants Country: Brazil
Overall mean age: not reported
Age range: not reported
Gender: not reported
Setting: refractive surgery service of the Eye Hospital of Paraná
Equivalence of baseline characteristics: baseline characteristics not reported
Inclusion criteria: myopia < 6.00 D, astigmatism < 3.00, and hyperopia < 5.00 D, stable refraction, corneal diameter < 11 mm, discontinuation of contact lens 7 days before the preoperative evaluation, BCVA of 20/20 in both eyes
Exclusion criteria: use of rigid gas permeable lens, dry eye and severe blepharitis, anterior segment abnormalities (cataract, corneal scar, neovascularization within 1 mm of the ablation area), recurrent corneal erosion, membrane disease severe basal, keratoconus or progressive or unstable myopia, corneal thickness resulting in < 250 μm in the residual bed, topography or preoperative aberrations (or both) indicating unfit eyes surgery for visual correction of LASIK, intraocular surgery, history of herpes keratitis, use of systemic corticosteroid, immunocompromised patients with significant atopic disease, connective tissue disease, diabetes mellitus, macular abnormalities, lactation, participation in other clinical trials
Interventions Laser for ablation: WaveLight Allegretto Wave Eye­Q Laser
Intervention 1
Intervention: LASIK with a Hansatome microkeratome
Flap dimensions: 160 μm thickness, 9.5 mm diameter, superior hinge
Number of people randomized: 19 eyes, 19 participants
Length of follow‐up:
Planned: not reported
Actual: 3 months
Intervention 2
Intervention: LASIK with a femto LDVTM Ziemer femtosecond laser
Flap dimensions: 110 μm thickness, 9.5 mm diameter, and superior hinge
Number of people randomized: 19 eyes, 19 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 month, and 3 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 3 months

  • Scale: not reported

  • Instrument for measurement: not reported

Identification Sponsorship source: not specified
Country: Brazil
Setting: Institute of Ophthalmology
Comments: none
Author's name: Alexander Rodrigo Hasimoto
Institution: Hospital de Olhos do Paraná – HOP, Curitiba (PR)
Email: tosa_alex@hotmail.com
Address: Rua Benjamin Constant, 788 – Ponta Grossa (PR) – 84010‐380
Notes Trial registration number: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The choice of eye and surgical technique for inclusion followed a random order (through opaque envelopes)."
Allocation concealment (selection bias) Low risk Quote: "The choice of eye and surgical technique for inclusion followed a random order (through opaque envelopes enumerated by order of arrival of patients, containing two papers with the name of the technique to be used and another opaque envelope containing two papers with right eye and left eye for both to be drawn; once a surgical technique was defined for a given eye, the contralateral eye received the other technique)."
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "participants did not know which surgical technique they were receiving in each eye."
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "outcome assessor, had no prior knowledge of the surgical technique administered in each eye."
Incomplete outcome data (attrition bias)
All outcomes High risk Quote: "Of a total of 19 patients proposed for the trial, 3 patients (6 eyes) were discontinued because they had complications. One patient suffered blunt trauma to one eye in the 10th postoperative day. Immediately the patient underwent surgical intervention to reposition the flap. At the end of the third month, there was an uncorrected visual acuity of 20/16 in this eye. One patient had diffuse lamellar keratitis (DLK) in only one eye (femtosecond group) at the end of the third day. Surgical intervention was required, showing good evolution, with uncorrected visual acuity of 20/25 in this eye. And the last patient presented blood cells at the flap interface, which required flap washing, with good evolution and visual acuity without correction of 20/20 at the end of the trial. Thus, every trial was based on the evaluation of 16 patients."
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