Patient Reported Outcomes With LASIK: PROWL-2

Completed

Conditions studied: Laser in Situ Keratomileusis

In brief

This study evaluates a questionaire designed to measure satisfaction and ophthalmic-related quality of life (QoL) of 300 civilian participants prior to and three months following state-of-the-art laser in situ keratomileusis (LASIK).

Key facts

Study ID

NCT01655420

Run by

Food and Drug Administration (FDA)

People needed

300

Starts

2012-07-01

Last updated by the study team

2018-02-08

Who can join

Age: 21 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Stanford University School of Medicine — Stanford, California, United States
• 20/20 Institute — Indianapolis, Indiana, United States
• Durrie Vision — Overland Park, Kansas, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Vance Thompson Vision — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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