Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain

Not Applicable

Completed

• Conditions: Pain; Vision Nearsighted
• Interventions: Device: Eye Shield

• Registration Number: NCT01592643
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

See above

Study Timeline

• Study Start: 2012-03-01
• Study First Submitted: 2012-04-19
• Study First Submitted QC: 2012-05-03
• Study First Posted: 2012-05-07
• Primary Completion: 2013-10-31
• Study Completion: 2013-10-31
• Status Verified: 2021-11
• Results First Submitted: 2021-11-24
• Results First Submitted QC: 2021-11-24
• Last Update Submitted: 2021-11-24
• Results First Posted: 2021-12-22
• Last Update Posted: 2021-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eye shield	Eye Shield	Participants receive eye shield during PRK surgery

Primary Outcome Measures

Name	Time	Method
Number of Participants With Pain Score of Four or Greater. Score Range: 0-10, Higher Score Corresponds to More Pain.	Day 30

Secondary Outcome Measures

Name	Time	Method
Mean Change in Uncorrected Visual Acuity	Six months	LogMAR uncorrected visual acuity. Values closer to zero indicate improved vision

Trial Locations

Locations (1)

Byers Eye Institute at Stanford; 🇺🇸 Palo Alto, California, United States