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

NCT01675375 | Completed DMC

• 1 other identifier: CS 004
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Post Laser Vision Correction Pain and Discomfort

Outcome Measures

Primary Outcomes (1)

• Evidence of maintaining vision and mitigating pain post Laser Vision Correction using an Eye Shield

  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

Study Arms (1)

Eye shield

EXPERIMENTAL

Eye shield place on post Laser Vision Correction eye

Device: Eye Shield

Interventions

Eye Shield DEVICE

one application following refractive surgery

Eye shield

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FORSIGHT Vision3: lead

Study Sites (5)

ClearView Eye and Laser

San Diego, California, 92121, United States

Location

Kraff Eye Institute

Chicago, Illinois, 60602, United States

Location

Talamo Laser Eye Consultants

Boston, Massachusetts, 02451, United States

Location

Physicians Protocol

Greensboro, North Carolina, 27410, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57105, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: August 29, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 5, 2013

Record last verified: 2013-02

Locations

US (5)