Influence of Cosmetic Color Tinted Contact Lenses on the Ocular Surface

This study has been completed.
Sponsor:
Collaborator:
National Taiwan University Hospital
Information provided by (Responsible Party):
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
ClinicalTrials.gov Identifier:
NCT01441648
First received: September 26, 2011
Last updated: January 17, 2014
Last verified: December 2011
  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

Resource links provided by NLM:


Further study details as provided by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation:

Primary Outcome Measures:
  • Comfort [ Time Frame: during 6 month weart ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: December 2011
Study Completion Date: December 2013
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:
  • cosmetic colored contact lenses
  • Ciba Vision Freshlook

  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
Study Population

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.

Criteria

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
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: NCT01441648

Locations
Taiwan
Buddhist Tzu Chi General Hospital, Taipei
New Taipei City, Taiwan, 23142
Sponsors and Collaborators
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
National Taiwan University Hospital
Investigators
Principal Investigator: Elizabeth P Shen Buddhist Tzu Chi General Hospital, Taipei Branch
  More Information

No publications provided

Responsible Party: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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: January 17, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation:
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 August 18, 2014