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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
FORSIGHT Vision3
ClinicalTrials.gov Identifier:
NCT01675375
First received: August 28, 2012
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Post Laser Vision Correction Pain and Discomfort
 Device: Eye Shield

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Laser Vision Correction Use of an Eye Shield for Maintaining Vision and Mitigating Pain

Further study details as provided by FORSIGHT Vision3:

Primary Outcome Measures:
  • Evidence of maintaining vision and mitigating pain post Laser Vision Correction using an Eye Shield [ Time Frame: 1yr ] [ Designated as safety issue: No ]
    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.


Enrollment: 125
Study Start Date: March 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eye shield
Eye shield place on post Laser Vision Correction eye
 Device: Eye Shield
one application following refractive surgery

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: FORSIGHT Vision3
ClinicalTrials.gov Identifier: NCT01675375     History of Changes
Other Study ID Numbers: CS 004
Study First Received: August 28, 2012
Last Updated: February 1, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013