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

NCT ID: NCT01675375

Last Updated: 2013-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-02-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Eye shield

Eye shield place on post Laser Vision Correction eye

Group Type: EXPERIMENTAL

Eye Shield

Intervention Type: DEVICE

one application following refractive surgery

Interventions

Eye Shield

one application following refractive surgery

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

FORSIGHT Vision3

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ClearView Eye and Laser

San Diego, California, United States

Kraff Eye Institute

Chicago, Illinois, United States

Talamo Laser Eye Consultants

Boston, Massachusetts, United States

Physicians Protocol

Greensboro, North Carolina, United States

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Countries

United States

Other Identifiers

CS 004

Identifier Type: -

Identifier Source: org_study_id