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 |
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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 |
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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 |
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Outcomes |
Adverse events reported: yes Diffuse lamellar keratitis
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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 |
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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 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 |