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OpenTrials
Completed

NCT Number: NCT01675375

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ClearView Eye and Laser, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eye Shield

Device

one application following refractive surgery

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

FORSIGHT Vision3

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 29, 2012
Registry last updated
Feb 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.