Patient Reported Outcomes With LASIK: PROWL-2

The LASIK Quality of Life Collaboration Project (LQOLCP) is a government partnership among
the FDA's Center for Devices and Radiological Health (CDRH), the Department of Defense, and
the National Eye Institute (NEI). This project examines patient-reported outcomes (PROs)
following LASIK surgery. This three-phased project is part of FDA's ongoing effort to better
monitor and improve the safety and effectiveness of lasers used in LASIK surgery. PROWL-2 is
the third phase of the larger LQOLCP project. The primary objective of PROWL-2 is to explore
the psychometric properties of a computer-based questionnaire assessing the patient-reported
outcomes of satisfaction and ophthalmic-related quality of life before and over a period of 3
months following LASIK. This questionnaire initially developed and examined in PROWL-1 (a
military population) will be examined psychometrically in a civilian population. PROWL-2 is a
prospective, multi-center, observational study in which a participant's pre-operative status
will serve as the baseline for one-month and three-month post-surgical comparisons. Three
hundred (300) participants planning to undergo refractive surgery using LASIK for myopia,
hyperopia, or astigmatism will be enrolled in this study from five (5) clinical sites across
the United States. Additionally, routine clinical data will be collected pre- and
post-operatively (e.g., best corrected visual acuity, manifest refraction, wavefront
aberrometry, conreal topography, and other clinical assessments) and questionnaires will be
independently administered pre-operatively and at the one-month and three-month
post-operative visits.

Inclusion Criteria:

- Investigators will be instructed to base subject eligibility on the Professional Use
Information for their specific laser and keratome system, including but not limited to
subjects who:

- Are aged 21 years or older.

- Have the ability to give informed consent.

- Speak and read English fluently.

- Have not previously had any form of refractive surgery, including prior LASIK or
cataract surgery.

- May benefit from increased spectacle independence.

- Have been determined to be a good candidate for the LASIK procedure based on the
investigator's assessment of medical and ophthalmic health, general cognitive
function, and physical and social limitations.

- Have a treatment target of bilateral emmetropia. Of note, an eye must be treated
within 7 days of the fellow eye.

- Express willingness and potential ability to return for all follow-up examinations
through the 3-month follow-up exam under the care of the treating investigator.

- Have access to a computer with internet service.