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Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain (Nexis-CS0032)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edward E. Manche, Stanford University
ClinicalTrials.gov Identifier:
NCT01592643
First received: April 19, 2012
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pain
Vision Nearsighted
 Device: Eye Shield
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Evidence of maintaining vision and mitigating pain post Photorefractive Keratectomy (PRK) using an Eye Shield [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Evidence of maintaining vision and mitigating pain post Photorefractive Keratectomy (PRK) using an Eye Shield by subjective patient questionnaires and objective imaging and slit lamp examination.


Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Eye Shield
    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 Name: Nexis Vision corneal shield
Detailed Description:

See above

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592643

Locations
United States, California
Byers Eye Institute at Stanford
Palo Alto, California, United States, 94303
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Edward E Manche, MD Stanford University
  More Information

No publications provided

Responsible Party: Edward E. Manche, Professor of Ophthalmology, Stanford University
ClinicalTrials.gov Identifier: NCT01592643     History of Changes
Other Study ID Numbers: 22760
Study First Received: April 19, 2012
Last Updated: October 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Corneal shield
PRK
Myopia
Pain
Vision

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013