Influence of Cosmetic Color Tinted Contact Lenses on the Ocular Surface
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Conjunctival Infections, Irritations and Inflammations Hypertrophy; Conjunctiva Corneal Pannus Corneal Epithelial Wound |
Other: contact lens wear |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Influence of Cosmetic Color Tinted Contact Lenses on the Ocular Surface |
- Comfort [ Time Frame: during 6 month weart ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
experimental group
(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.
|
Other: contact lens wear
tinted contact lens wear
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 20 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
- Age 20-35 years old
- myopia less than -6.00 D, Astigmatism less than 1.50 D
- previous soft contact lens wear discontinued for at least 2 weeks
Exclusion Criteria:
- subjects with previous Rigid Gas Permeable wear
- Any ocular surgery or topical medication
- dry eye syndrome
- glaucoma
- ocular trauma
- pregnancy
- any corneal disorders or dystrophies
Contacts and Locations| Taiwan | |
| Buddhist Tzu Chi General Hospital, Taipei | |
| New Taipei City, Taiwan, 23142 | |
| Principal Investigator: | Elizabeth P Shen | Buddhist Tzu Chi General Hospital, Taipei Branch |
More Information
No publications provided
| Responsible Party: | Buddhist Tzu Chi General Hospital, Taipei |
| ClinicalTrials.gov Identifier: | NCT01441648 History of Changes |
| Other Study ID Numbers: | 00-IRB-007-XD, Shen EP |
| Study First Received: | September 26, 2011 |
| Last Updated: | February 12, 2013 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Buddhist Tzu Chi General Hospital, Taipei:
|
conjunctival injection conjunctival papillary hypertrophy pannus formation corneal epitheliopathy Schirmer test |
Impression cytology confocal microscopy Scanning electronmicroscopy (SEM) bacterial adhesion determination |
Additional relevant MeSH terms:
|
Hypertrophy Inflammation Corneal Neovascularization Pathological Conditions, Anatomical |
Pathologic Processes Corneal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 23, 2013