Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain (Nexis-CS0032)
The purpose of this research is to determine if an investigational thin shield over the cornea can safely and effectively reduce or eliminate pain following Post Photorefractive Keratectomy (PRK).
The thin shield is made of silicone. The materials used to make the corneal shield all have a history of use in medical devices, contact lenses, and/or corneal shields and have been used safely in the eye.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain|
- Evidence of maintaining vision and mitigating pain post Photorefractive Keratectomy (PRK) using an Eye Shield [ Time Frame: 1 month ] [ Designated as safety issue: No ]Evidence of maintaining vision and mitigating pain post Photorefractive Keratectomy (PRK) using an Eye Shield by subjective patient questionnaires and objective imaging and slit lamp examination.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Device: Eye Shield
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592643
|United States, California|
|Byers Eye Institute at Stanford|
|Palo Alto, California, United States, 94303|
|Principal Investigator:||Edward E Manche, MD||Stanford University|