Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain
This trial is active, not recruiting.
|Conditions||pain, vision nearsighted|
|Start date||March 2012|
|End date||December 2017|
|Trial size||30 participants|
|Trial identifier||NCT01592643, 22760|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Primary purpose||supportive care|
Evidence of maintaining vision and mitigating pain post Photorefractive Keratectomy (PRK) using an Eye Shield
time frame: 1 month
Male or female participants at least 18 years old.
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
|Official title||Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain|
|Principal investigator||Edward E Manche, MD|
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