Sponsor study identifier
Secondary identifiers
OTHER · Buddhist Tzu Chi General Hospital, Taipei
observational
14
1 country
1
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)More than 1 million people worldwide wear soft contact lenses for refractive error correction. However, severe sight threatening complications due to contact lens wear such as contact lens-related microbial keratitis (CLMK) are about 1 per 2500 persons per year. The rate of infection increases drastically to 1 per 500 person per year if lenses were worn overnight. Recently, color tinted cosmetic soft contact lenses, which are essentially soft contact lenses with a color tinted annular ring, are gaining increasing popularity especially among the younger and Asian population desiring a change in iris color or the doll-eyed look. However, studies on the effect of these lenses on the ocular surface have been scarce. Recently, a report of 12 cases of lens-related microbial keratitis due to wear of the color tinted lenses have been reported. Others reported of decreased contrast sensitivity, increased higher order aberrations, and temporary changes in corneal topography due to color tinted lens wear. Nevertheless, comprehensive and prospective study has not yet been done. Thus, the purpose of this study is to conduct a prospective observational study to determine the influence of color tinted cosmetic contact lens wear both on visual performance and ocular surface alterations.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 26, 2011
Actual (reported)September 28, 2011
Actual (reported)December 2011
Date type not reportedThis date has not been verified as actual or estimated.
December 2013
Actual (reported)December 2013
Actual (reported)Comfort
during 6 month weart
(1) age 20-35 years old (2) myopia less than -6.00D and astigmatism less than -1.50D (3) previous soft contact lens wear discontinued for at least 2 weeks. Exclusion criteria includes: (1) subjects with previous Rigid Gas Permeable (RGP) wear (2) any ocular inflammation or infection, dry eye syndrome, glaucoma, ocular trauma or surgery, and topical medication instillation (3) diabetic mellitus (4) pregnancy (5) any corneal disorders or dystrophies.
tinted contact lens wear
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
1\) age 20-35 years old (2) myopia less than -6.00D and astigmatism less than -1.50D (3) previous soft contact lens wear discontinued for at least 2 weeks. Exclusion criteria includes: (1) subjects with previous Rigid Gas Permeable wear (2) any ocular inflammation or infection, dry eye syndrome, glaucoma, ocular trauma or surgery, and topical medication instillation (3) diabetic mellitus (4) pregnancy (5) any corneal disorders or dystrophies.
Buddhist Tzu Chi General Hospital, Taipei
New Taipei City, 23142, Taiwan
Elizabeth P Shen
Buddhist Tzu Chi General Hospital, Taipei Branch
14 participants (actual enrollment reported by the registry).
First Submitted
September 26, 2011
First Posted
September 28, 2011
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)Last Updated
January 20, 2014
Record last verified: 2011-12
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Source: ClinicalTrials.gov.
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