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OpenTrials
Completed

NCT Number: NCT01592643

Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain

The purpose of this research is to determine if an investigational thin shield over the cornea can safely and effectively reduce or eliminate pain following Post Photorefractive Keratectomy (PRK).

The thin shield is made of silicone. The materials used to make the corneal shield all have a history of use in medical devices, contact lenses, and/or corneal shields and have been used safely in the eye.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

About this study

See above

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

.

  • Subjects age 18 and older with healthy eyes.
  • Nearsightedness between -0.50 diopters and -11.00 diopters with or without astigmatism of up to 3.50 diopters.

Exclusion criteria

.

  • Subjects under the age of 18.
  • Patients with excessively thin corneas.
  • Patients with topographic evidence of keratoconus.
  • Patients with ectactic eye disorders.
  • Patients with autoimmune diseases.
  • Patients who are pregnant or nursing.
  • Any other anterior segment abnormality other than that associated with PRK
  • 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

Treatment and study plan

Eye Shield

Device

The thin shield is made of silicone. The materials used to make the corneal shield all have a history of use in medical devices, contact lenses, and/or corneal shields and have been used safely in the eye.

Other names: Nexis Vision corneal shield

Primary outcomes

  1. Number of Participants With Pain Score of Four or Greater. Score Range: 0-10, Higher Score Corresponds to More Pain.

    Time frame: Day 30

Secondary outcomes

  1. Mean Change in Uncorrected Visual Acuity

    Time frame: Six months

    LogMAR uncorrected visual acuity. Values closer to zero indicate improved vision

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: Nexis-CS0032

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 7, 2012
Registry last updated
Dec 22, 2021

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.

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