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IntraLase vs Hansatome Flaps in LASIK

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ClinicalTrials.gov Identifier: NCT00691431
Recruitment Status : Completed
First Posted : June 5, 2008
Last Update Posted : June 2, 2011
Sponsor:
Information provided by:
Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myopia Device: LASIK Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the IntraLaser Femtosecond Laser and Hansatome Mechanical Keratome for Laser In Situ Keratomileusis
Study Start Date : May 2004
Study Completion Date : November 2005

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Primary Outcome Measures :
  1. Visual acuity

Secondary Outcome Measures :
  1. Contrast sensitivity


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691431


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Edward E. Manche Stanford University

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Responsible Party: Edward E. Manche, Principal Investigator, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00691431     History of Changes
Other Study ID Numbers: SU-05302008-1190
First Posted: June 5, 2008    Key Record Dates
Last Update Posted: June 2, 2011
Last Verified: June 2008