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IntraLase vs Hansatome Flaps in LASIK

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00691431
Recruitment Status : Completed
First Posted : June 5, 2008
Last Update Posted : June 2, 2011
Sponsor:
Information provided by:
Stanford University

Tracking Information
First Submitted Date  ICMJE June 3, 2008
First Posted Date  ICMJE June 5, 2008
Last Update Posted Date June 2, 2011
Study Start Date  ICMJE May 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
Visual acuity
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
Contrast sensitivity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IntraLase vs Hansatome Flaps in LASIK
Official Title  ICMJE Comparison of the IntraLaser Femtosecond Laser and Hansatome Mechanical Keratome for Laser In Situ Keratomileusis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myopia
Intervention  ICMJE Device: LASIK
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 3, 2008)
51
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00691431
Other Study ID Numbers  ICMJE SU-05302008-1190
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Edward E. Manche, Principal Investigator, Stanford University School of Medicine
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edward E. Manche Stanford University
PRS Account Stanford University
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP