Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain (Nexis-CS0032)
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|ClinicalTrials.gov Identifier: NCT01592643|
Recruitment Status : Active, not recruiting
First Posted : May 7, 2012
Last Update Posted : April 24, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain Vision Nearsighted||Device: Eye Shield||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2020|
- Device: Eye Shield
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.Other Name: Nexis Vision corneal shield
- Evidence of maintaining vision and mitigating pain post Photorefractive Keratectomy (PRK) using an Eye Shield [ Time Frame: 1 month ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592643
|United States, California|
|Byers Eye Institute at Stanford|
|Palo Alto, California, United States, 94303|
|Principal Investigator:||Edward E Manche, MD||Stanford University|