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

February 1, 2013 updated by: FORSIGHT Vision3
The purpose of this research is to determine if an investigational thin shield can effectively reduce discomfort following Laser Vision Correction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1yr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FORSIGHT Vision3

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

August 28, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (Estimate)

August 29, 2012

Study Record Updates

Last Update Posted (Estimate)

February 5, 2013

Last Update Submitted That Met QC Criteria

February 1, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • CS 004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post Laser Vision Correction Pain and Discomfort

Clinical Trials on Eye Shield

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe