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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014