Status:
UNKNOWN
Corneal Thickness Changes With Scleral Contact Lenses
Lead Sponsor:
University of Waterloo
Collaborating Sponsors:
Bausch & Lomb Incorporated
Conditions:
Keratoconus
Healthy Controls
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to investigate changes in the corneal thickness of scleral contact lens wearers in a keratoconic (KC) population and compare to age-matched controls. The hypothesis is tha...
Detailed Description
The purpose of this study is to investigate changes in the corneal thickness of scleral contact lens wearers in a keratoconic (KC) population and compare to age-matched controls. The hypothesis is tha...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Test Group):
- Had been diagnosed with keratoconus in at least one eye.
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and understood the information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Inclusion Criteria (Control Group)
- Had been NOT diagnosed with keratoconus in at least one eye.
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and understood the information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Exclusion Criteria (Test Group):
- Is using any topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (severe dry eyes) that would affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities and active neovascularization.
- Is aphakic.
- Has undergone penetrating keratoplasty.
- Is participating in any other type of eye related clinical or research study.
- Has any known allergies or sensitivity to the diagnostic pharmaceuticals or products, such as fluorescein, used in this study.
- Exclusion Criteria (Control Group):
- Is using any topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (severe dry eyes) that would affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities and active neovascularization.
- Is aphakic.
- Has undergone any corneal surgery.
- Is participating in any other type of eye related clinical or research study.
- Has any known allergies or sensitivity to the diagnostic pharmaceuticals or products, such as fluorescein, used in this study.
Exclusion
Key Trial Info
Start Date :
June 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03249233
Start Date
June 22 2017
End Date
December 1 2020
Last Update
April 10 2020
Active Locations (1)
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1
University of Waterloo School of Optometry and Vision Science
Waterloo, Ontario, Canada, N2L3G1