Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain (Nexis-CS0032)

Stanford University

Status

Completed

Conditions

Vision Nearsighted

Pain

Treatments

Device: Eye Shield

Study type

Interventional

Funder types

Other

Identifiers

NCT01592643

22760

Details and patient eligibility

About

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.

Full description

See above

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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