This study is a single-site, single-arm, prospective, observational study of subject satisfaction, quality of vision, and quality of life after bilateral LASIK surgery. Subjects will be assessed 6 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the adapted PROWL, QIRC, and OSDI questionnaires.
Study Type
OBSERVATIONAL
Enrollment
60
The WaveLight EX500 laser system, in conjunction with INNOVEYES Sightmap, is indicated for use in INNOVEYES Laser Assisted In-Situ Keratomileusis ("wavelight plus"1 LASIK) treatments: * or the reduction or elimination of myopia or myopia with astigmatism, in eyes with spherical equivalent (SE) more than -1.00 and up to -9.00 diopters (D), with up to -8.00 D of spherical component (in minus cylinder format) and up to -3.00 D of astigmatic component at the spectacle plane, based on the INNOVEYES Sightmap Measured Refraction, * in patients with magnitude of the spherical equivalent (SE) difference between the Manifest Refraction (MRSE) and the Sightmap measured refraction SE being less than 0.75D, * in patients who are 18 years of age or older, and * for patients with documentation of a stable manifest refraction defined as 0.5 D preoperative spherical equivalent shift over one year prior to surgery.
Ovo Lasik + Lens
Saint Louis Park, Minnesota, United States
Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight Plus LASIK based on an adapted PROWL Questionnaire (Question #1 only).
Time frame: 6 months postoperatively
Remaining Vision quality and quality of life during daily tasks using the adapted PROWL
Time frame: 6 months postoperatively
The percentage of eyes at each monocular visual acuity (VA) level (uncorrected 20/10, 20/12.5, 20/16, 20/20, 20/25).
Time frame: 6 months postoperatively
The percentage of subjects at each binocular visual acuity (VA) level (uncorrected 20/10, 20/12.5, 20/16, 20/20, 20/25).
Time frame: 6 months postoperatively
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