Laser Vision Correction Use of an Eye Shield for Maintaining Vision and Mitigating Pain

Study Overview
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Brief Summary
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The purpose of this research is to determine if an investigational thin shield can effectively reduce discomfort following Laser Vision Correction.

Official Title
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Laser Vision Correction Use of an Eye Shield for Maintaining Vision and Mitigating Pain

Conditions
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Post Laser Vision Correction Pain and Discomfort

Intervention / Treatment
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* Device: Eye Shield


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled to undergo Laser Vision Correction for correction of refractive error FDA approved treatment guidelines for Laser Vision Correction Age 18-60 Patients able to understand the requirements of the study, willing to follow study instructions, provide written informed consent to participate, and comply with all study requirements, including the required study follow-up visits Exclusion Criteria: Any other anterior segment abnormality other than that associated with LAser Vision Correction Any abnormalities associated with the eye lids Uncontrolled blepharitis or dry eye Prior laser treatment of the retina Any ophthalmic surgery performed within three (3) months prior to study excluding PRK or LASIK Diagnosis of glaucoma Active diabetic retinopathy Clinically significant inflammation or infection within six (6) months prior to study Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational material Intolerance or hypersensitivity to topical anesthetics, antibiotics, steroids or any other pharmaceuticals that may be used pre and post surgically Specifically known intolerance or hypersensitivity to contact lenses or any component of the investigative material A medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eye shield<br>Eye shield place on post Laser Vision Correction eye | Device: Eye Shield<br>* one application following refractive surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of maintaining vision and mitigating pain post Laser Vision Correction using an Eye Shield | Evidence of maintaining vision and mitigating pain post Laser Vision Correction using an Eye Shield by subjective patient questionnaires and objective imaging and slit lamp examination. | 1yr |