ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01675375
Recruitment Status : Completed
First Posted : August 29, 2012
Last Update Posted : February 5, 2013
Sponsor:
Information provided by (Responsible Party):
FORSIGHT Vision3

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

Condition or disease Intervention/treatment Phase
Post Laser Vision Correction Pain and Discomfort Device: Eye Shield Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Laser Vision Correction Use of an Eye Shield for Maintaining Vision and Mitigating Pain
Study Start Date : March 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Arm Intervention/treatment
Experimental: Eye shield
Eye shield place on post Laser Vision Correction eye
Device: Eye Shield
one application following refractive surgery




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675375


Locations
United States, California
ClearView Eye and Laser
San Diego, California, United States, 92121
United States, Illinois
Kraff Eye Institute
Chicago, Illinois, United States, 60602
United States, Massachusetts
Talamo Laser Eye Consultants
Boston, Massachusetts, United States, 02451
United States, North Carolina
Physicians Protocol
Greensboro, North Carolina, United States, 27410
United States, South Dakota
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
FORSIGHT Vision3

Responsible Party: FORSIGHT Vision3
ClinicalTrials.gov Identifier: NCT01675375     History of Changes
Other Study ID Numbers: CS 004
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013