NCT01675375CompletedNot Applicable
Laser Vision Correction Use of an Eye Shield for Maintaining Vision and Mitigating Pain
FORSIGHT Vision310 sites in 1 country125 target enrollmentStarted: March 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 125
- Locations
- 10
- Primary Endpoint
- Evidence of maintaining vision and mitigating pain post Laser Vision Correction using an Eye Shield
Study Overview
Brief Summary
The purpose of this research is to determine if an investigational thin shield can effectively reduce discomfort following Laser Vision Correction.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Evidence of maintaining vision and mitigating pain post Laser Vision Correction using an Eye Shield
Time Frame: 1yr
Evidence of maintaining vision and mitigating pain post Laser Vision Correction using an Eye Shield by subjective patient questionnaires and objective imaging and slit lamp examination.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (10)
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