IntraLase vs Hansatome Flaps in LASIK

Not Recruiting

Trial ID: NCT00691431


This study compared the clinical outcomes between fellow eyes randomized to either IntraLase femtosecond laser-created flaps or Hansatome mechanical keratome-created flaps during wavefront-guided laser in situ keratomileusis.

Official Title

Comparison of the IntraLaser Femtosecond Laser and Hansatome Mechanical Keratome for Laser In Situ Keratomileusis

Stanford Investigator(s)

Edward Manche, MD
Edward Manche, MD

Professor of Ophthalmology


Inclusion Criteria:

Inclusion criteria were "T 6.00 D of spherical myopia, "T 3.00 D of refractive astigmatism,
stable refraction (less than 0.50D per year of sphere or cylinder), corneal diameter less
than 11.0 mm to allow for suction fixation ring, soft contact wearer with discontinuation
of wear at least 7 days prior to preoperative evaluation, visual acuity correctable to at
least 20/20 in both eyes, more than 21 years of age, ability to participate in follow-up
examinations for 12 months after LASIK surgery. In order to fairly compare the visual
outcomes of the two keratomes, patients were required to have closely matched eyes, in
terms of refractive error. Exclusion Criteria:Exclusion criteria include rigid gas
permeable contact lens wearer, severe dry eyes, severe blepharitis, anterior segment
pathology (cataracts or corneal scarring or neovascularization within 1 mm of intended
ablation zone), recurrent corneal erosion, severe basement membrane disease, progressive or
unstable myopia or keratoconus, unstable corneal mires on central keratometry, corneal
thickness in which LASIK procedure would result in less than 250 micros or remaining
posterior corneal thickness below the flap postoperatively, baseline standard manifest
refraction > 0.75 D more minus in sphere power, or a difference of greater than 0.50D in
cylinder power compared to baseline standard cycloplegic refraction, two eyes for which the
baseline standard cycloplegic refraction differ from each other more than 0.75 in sphere,
0.50 D in cylinder, or have a different type of astigmatism (i.e. with-the-rule) when the
cylinder is > 0.50D, or preoperative assessment of ocular topography and/or aberrations
indicates that either eye is not suitable candidate for LASIK vision correction procedure
(ie forme fruste keratoconus, corneal warpage, or pellucid marginal degeneration), previous
intraocular or corneal surgery, and history of herpes zoster or simplex keratitis, patients
on systemic corticosteroid or immunosuppressive therapy, immunocompromised subjects or
clinically significant atopic disease, connective tissue disease, or diabetes, steroid
responder, macular pathology, pregnant or lactating patients, patients with sensitivity to
planned study concomitant medications or patients participating in another ophthalmic drug
or device clinical trial.


device: LASIK

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Annie Chan