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Retrospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01444053
First received: August 30, 2011
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to examine the long term effect of ultra-violet filtering contact lenses on macular pigment density (MPOD) and accommodative function.


Condition
Refractive Errors

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Macular Pigment Ocular Density (MPOD) after 5 years of contact lens wear [ Time Frame: measured at a single visit ] [ Designated as safety issue: No ]
    The MPOD will be assessed at a single visit will be compared between wearers of contact lenses with UV protection and those wearers of lenses without UV protection, based on their 5 year wear history.

  • Amplitude of Accommodation after 5 years of contact lens wear [ Time Frame: measured at a single visit ] [ Designated as safety issue: No ]
    Measured with autorefractor at a single visit and will be compared between wearers of contact lenses with UV protection and those wearers of lenses without UV protection, based on their 5 year wear history.


Enrollment: 41
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Wearers of contact lenses without UV Protection
Subjects who have worn a soft contact lens without UV protection for the past five years or more.
Wearers of contact lenses with UV Protection
Subjects who have worn a soft contact lens with UV protection for the last 5 years or more.

  Eligibility

Ages Eligible for Study:   18 Years to 43 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subject selection is based on a history of wearing one of two types of contact lenses for at least five years. Age-matching subjects into 4 age-brackets will be attempted with a target of five subjects in each age bracket among the two types of lenses.

Criteria

Inclusion Criteria:

  • The subject is an adapted soft contact lens wearer of at least 5 years duration of either an UV filtering contact lens or a non-UV filtering contact lens
  • The subject must report wearing their contact lenses, on average, for a minimum of 5 days each week.
  • The subject must have best corrected visual acuity of 6/7.5 or better in each eye.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • The subject must read and sign the statement of informed consent
  • The subject must be between 18 and 43 years of age

Exclusion Criteria:

  • On medication known to affect accommodation
  • Active ocular surface pathology
  • Had eye surgery
  • Significant ocular tissue anomaly
  • Any medical condition that may be prejudicial to the study
  • Diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444053

Locations
United Kingdom
Birmingham, United Kingdom
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01444053     History of Changes
Other Study ID Numbers: CR-201010
Study First Received: August 30, 2011
Last Updated: May 7, 2012
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013