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



Status:Recruiting
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:March 2012
Contact:Ashley Tuan, OD, PhD
Email:atuan@nexisvision.com
Phone:6503252050

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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.


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
We found this trial at
5
sites
Boston, Massachusetts 02451
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Chicago, Illinois 60602
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Chicago, IL
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Greensboro, North Carolina 27410
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San Diego, California 92121
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Sioux Falls, South Dakota 57105
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Sioux Falls, SD
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