Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

August 28, 2012
February 1, 2013
March 2012
February 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01675375 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Laser Vision Correction Use of an Eye Shield for Maintaining Vision and Mitigating Pain
Laser Vision Correction Use of an Eye Shield for Maintaining Vision and Mitigating Pain

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

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Post Laser Vision Correction Pain and Discomfort
Device: Eye Shield
one application following refractive surgery
Experimental: Eye shield
Eye shield place on post Laser Vision Correction eye
Intervention: Device: Eye Shield
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01675375
CS 004
Yes
FORSIGHT Vision3
FORSIGHT Vision3
Not Provided
Not Provided
FORSIGHT Vision3
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP