An Evaluation of Outcomes Following Wavefront Optimized or Wavefront Guided Lasik Procedure in Lo… (NCT01173198) | Clinical Trial Compass
CompletedPhase 4
An Evaluation of Outcomes Following Wavefront Optimized or Wavefront Guided Lasik Procedure in Low to Moderate Myopic Patients
United States37 participantsStarted 2009-11
Plain-language summary
To compare post-surgical outcomes in patients who have undergone Wavefront Guided LASIK (iLASIK platform) compared with patients who have undergone Wavefront Optimized LASIK (Wavelight Allegretto 400 Hz platform).
Who can participate
Age range21 Years – 35 Years
SexALL
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Inclusion Criteria:
* The subject must be male or female, of any race, and at least 21 years old and not older than 35 years old at the time of the pre-operative examination;
* Both eyes must have a BSCVA of 20/20 or better;
* Both eyes must have a manifest refractive error from -2.00 D to -6.00 D, a cylinder component up to -1.50 D, and a maximum manifest spherical equivalent of -6.00 D;
* Both eyes must have at least 0.2 microns RMS HOA
* Both eyes must have a minimum pupil size of at least 6.0mm in dim illumination on wavescan;
* Both eyes must demonstrate refractive stability confirmed by clinical records or previous glasses. Refractive stability shall be documented by a change of less than or equal to 0.50 diopter (sphere and cylinder) at an exam at least 12 months prior to the baseline examination. The astigmatic axis must also be within 15 degrees for eyes with cylinder greater than 0.50 D; and
* Subjects should be willing and capable of returning for follow-up examinations for the duration of the study.
Exclusion Criteria:
* Use of systemic or ocular medications that may affect vision
* Subjects who use concurrent topical or systemic medications that may impair healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment; NOTE: The use of topical or systemic corticosteroids, whether chronic or acute, is deemed to adversely affect healing and sub…
What they're measuring
1
Reduction or elimination of myopia and myopic astigmatism