Post Laser Vision Correction Pain and Discomfort Clinical Trial
Official title:
Laser Vision Correction Use of an Eye Shield for Maintaining Vision and Mitigating Pain
| Verified date | February 2013 |
| Source | FORSIGHT Vision3 |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The purpose of this research is to determine if an investigational thin shield can effectively reduce discomfort following Laser Vision Correction.
| Status | Completed |
| Enrollment | 125 |
| Est. completion date | February 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United States | Talamo Laser Eye Consultants | Boston | Massachusetts |
| United States | Kraff Eye Institute | Chicago | Illinois |
| United States | Physicians Protocol | Greensboro | North Carolina |
| United States | ClearView Eye and Laser | San Diego | California |
| United States | Vance Thompson Vision | Sioux Falls | South Dakota |
| Lead Sponsor | Collaborator |
|---|---|
| FORSIGHT Vision3 |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evidence of maintaining vision and mitigating pain post Laser Vision Correction using an Eye Shield | 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. | 1yr | No |