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Safety of Overnight Corneal Reshaping Lenses

This study has been completed.
Sponsor:
Collaborators:
Bausch & Lomb Incorporated
Paragon Vision Sciences
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT01272271
First received: January 6, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

This retrospective chart review study compares the incidence of corneal inflammation due to infection in children vs. adult patients wearing overnight corneal reshaping lenses.


Condition
Keratitis
Myopia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Postmarket Study of the Safety of Overnight Corneal Reshaping Lenses

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Microbial keratitis incidence [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Incidence of microbial keratitis in children vs. adults with the use of two brands of corneal reshaping lenses.


Enrollment: 1317
Study Start Date: February 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children
Adults

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Randomized sample of optometry and ophthalmology patients seen by 200 practitioners in various practice settings, stratified on manufacturer, practitioner volume.

Criteria

Inclusion Criteria:

  • Patients completing at least 3 months of wearing corneal reshaping lenses

Exclusion Criteria:

  • Less than 3 months of wearing corneal reshaping lenses
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272271

Sponsors and Collaborators
Ohio State University
Bausch & Lomb Incorporated
Paragon Vision Sciences
Investigators
Principal Investigator: Mark A Bullimore, PhD Ohio State University
  More Information

No publications provided

Responsible Party: Mark A. Bullimore, Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01272271     History of Changes
Other Study ID Numbers: 2007H0273
Study First Received: January 6, 2011
Last Updated: January 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Contact lens
Infection
Cornea

Additional relevant MeSH terms:
Keratitis
Myopia
Corneal Diseases
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on May 21, 2013