Post Photorefractive Keratectomy (PRK) 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 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
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See above

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

Conditions
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Pain, Vision Nearsighted

Intervention / Treatment
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* Device: Eye Shield


Participation Criteria
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Eligibility Criteria
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Inclusion criteria. Subjects age 18 and older with healthy eyes. Nearsightedness between -0.50 diopters and -11.00 diopters with or without astigmatism of up to 3.50 diopters. Exclusion criteria. Subjects under the age of 18. Patients with excessively thin corneas. Patients with topographic evidence of keratoconus. Patients with ectactic eye disorders. Patients with autoimmune diseases. Patients who are pregnant or nursing. Any other anterior segment abnormality other than that associated with PRK 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

Ages Eligible for Study
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Minimum Age: 18 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>Participants receive eye shield during PRK surgery | Device: Eye Shield<br>* 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.<br>* Other names: Nexis Vision corneal shield;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Uncorrected Visual Acuity | LogMAR uncorrected visual acuity. Values closer to zero indicate improved vision | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corneal shield, PRK, Myopia, Pain, Vision