Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Chronic Pain, Ocular |
| Therapuetic Areas: | Musculoskeletal, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | March 2012 |
| End Date: | December 2020 |
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.
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.
See above
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
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