Clinical trial NCT01675375: Laser Vision Correction Use of an Eye Shield for Maintaining Vision and Mitigating Pain
Official title: Laser Vision Correction Use of an Eye Shield for Maintaining Vision and Mitigating Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Laser Vision Correction Pain and Discomfort
Lead sponsor: FORSIGHT Vision3
Sponsor class: INDUSTRY
First posted: 2012-08-29
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to determine if an investigational thin shield can effectively reduce discomfort following Laser Vision Correction.


Eligibility criteria: 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

Primary outcomes:
measure: Evidence of maintaining vision and mitigating pain post Laser Vision Correction using an Eye Shield
timeFrame: 1yr
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: ClearView Eye and Laser
state: California
city: Chicago
country: United States
facility: Kraff Eye Institute
state: Illinois
city: Boston
country: United States
facility: Talamo Laser Eye Consultants
state: Massachusetts
city: Greensboro
country: United States
facility: Physicians Protocol
state: North Carolina
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
Study officials:
References: