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

Completed

• Conditions: Refractive Errors
• Interventions: Device: No Intervention

• Registration Number: NCT01444053
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-01
• Study First Submitted: 2011-08-30
• Study First Submitted QC: 2011-09-28
• Study First Posted: 2011-09-30
• Primary Completion: 2011-12-01
• Study Completion: 2011-12-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-16
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Wearers of contact lenses with UV Protection	No Intervention	Subjects who have worn a soft contact lens with UV protection for the last 5 years or more.
Wearers of contact lenses without UV Protection	No Intervention	Subjects who have worn a soft contact lens without UV protection for the past five years or more.

Primary Outcome Measures

Name	Time	Method
Macular Pigment Optical Density (MPOD) after 5 years of contact lens wear	Approximately 40 minutes	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	Approximately 40 minutes	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.