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

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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Device: No Intervention

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: No Intervention; No Intervention
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.	Device: No Intervention; No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular Pigment Optical Density (MPOD) after 5 years of contact lens wear	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.	Approximately 40 minutes
Amplitude of Accommodation after 5 years of contact lens wear	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.	Approximately 40 minutes

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: August 30, 2011
• First Submitted That Met QC Criteria: September 28, 2011
• First Posted (Estimate): September 30, 2011

Study Record Updates

• Last Update Posted (Actual): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 16, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CR-201010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes