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

Not Applicable

Completed

• Conditions: Post Laser Vision Correction Pain and Discomfort
• Interventions: Device: Eye Shield

• Registration Number: NCT01675375
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-29
• Status Verified: 2013-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Last Update Submitted: 2013-02-01
• Last Update Posted: 2013-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eye shield	Eye Shield	Eye shield place on post Laser Vision Correction eye

Primary Outcome Measures

Name	Time	Method
Evidence of maintaining vision and mitigating pain post Laser Vision Correction using an Eye Shield	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.

Trial Locations

Locations (5)

Kraff Eye Institute; 🇺🇸 Chicago, Illinois, United States

ClearView Eye and Laser; 🇺🇸 San Diego, California, United States

Talamo Laser Eye Consultants; 🇺🇸 Boston, Massachusetts, United States

Vance Thompson Vision; 🇺🇸 Sioux Falls, South Dakota, United States

Physicians Protocol; 🇺🇸 Greensboro, North Carolina, United States