Influence of Cosmetic Color Tinted Contact Lenses on the Ocular Surface

NCT01441648 | Completed

• 2 other identifiers: 00-IRB-007-XDShen EP
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Conjunctival Infections, Irritations and Inflammations; Hypertrophy; Conjunctiva; Corneal Pannus; Corneal Epithelial Wound

Keywords

conjunctival injection; conjunctival papillary hypertrophy; pannus formation; corneal epitheliopathy; Schirmer test; Impression cytology; confocal microscopy; Scanning electronmicroscopy (SEM); bacterial adhesion determination

Outcome Measures

Primary Outcomes (1)

• Comfort

  during 6 month weart

Study Arms (1)

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

Interventions

contact lens wear OTHER

tinted contact lens wear

Also known as: cosmetic colored contact lenses, Ciba Vision Freshlook

experimental group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead
• National Taiwan University Hospital: collaborator

Study Sites (1)

Buddhist Tzu Chi General Hospital, Taipei

New Taipei City, 23142, Taiwan

Location

MeSH Terms

Conditions

Inflammation; Hypertrophy

Interventions

Contact Lenses, Extended-Wear

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Contact Lenses, Hydrophilic; Contact Lenses; Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Elizabeth P Shen

  Buddhist Tzu Chi General Hospital, Taipei Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: September 28, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 20, 2014

Record last verified: 2011-12

Locations

TW (1)