This study is a multi-site, single-arm, ambispective, observational study of subject satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed 12+ months post-operatively. Clinical evaluations will include administration of the OSDI, modified PROWL, and dry eye questionnaires.
Study Type
OBSERVATIONAL
Enrollment
300
Phorcidies Planned Contoura LASIK
NVISION Eye Centers
San Diego, California, United States
Boston Vision
Brookline, Massachusetts, United States
Ovo Lasik + Lens
Saint Louis Park, Minnesota, United States
Mann Eye Institute
Houston, Texas, United States
Patient Satisfaction
Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight LASIK based on a modified PROWL Questionnaire (Question #1 only).
Time frame: 12 months postoperatively
PROWL Questionnaire
PROWL-SS can be used to assess satisfaction with vision and the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items). Subjects select one of 6 responses for each question.
Time frame: 12 months postoperatively
OSDI Questionnaire
The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.
Time frame: 12 months postoperatively
Percentage of Subjects Using Artificial Tears or Prescription Dry Eye Medication.
Time frame: 12 months postoperatively
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