Completed
Laser Vision Correction Use of an Eye Shield for Maintaining Vision and Mitigating Pain
What is being tested
Eye Shield
Device
Who is being recruted
From 18 to 60 Years
+19 Eligibility Criteria
How is the trial designed
Supportive Care Study
Interventional
Study Start: March 2012
Summary
Principal SponsorFORSIGHT Vision3
Last updated: February 5, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2012
Actual date on which the first participant was enrolled.The purpose of this research is to determine if an investigational thin shield can effectively reduce discomfort following Laser Vision Correction.
Principal SponsorFORSIGHT Vision3
Last updated: February 5, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
125 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
4 inclusion criteria required to participate
Age 18-60
FDA approved treatment guidelines for Laser Vision Correction
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
Patients scheduled to undergo Laser Vision Correction for correction of refractive error
15 exclusion criteria prevent from participating
A medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up
Active diabetic retinopathy
Any abnormalities associated with the eye lids
Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalEye shield place on post Laser Vision Correction eye
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
Kraff Eye Institute
Chicago, United StatesTalamo Laser Eye Consultants
Boston, United StatesPhysicians Protocol
Greensboro, United StatesCompleted5 Study Centers