Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2017-06-22
2020-12-31
Brief Summary
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Detailed Description
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This will be a prospective, dispensing study design. The study will involve up to 20 keratoconic participants and up to 20 age matched controls. Participants will attend 1 screening/fitting visit wearing their habitual contact lenses where the two test lens designs (350 and 450microns) will be fitted. There will then be a delivery visit for each design (randomly selected) and a single follow up visit after 8-10 hours of scleral lens wear, three weeks later. A washout period of a minimum of 48 hours will be applied between the cross-over of each lens design. Lenses to be worn in this study will be made of Boston XO material and are approved by Health Canada. The lenses will have a diameter of 14.8-17.0mm with a high and low sagittal depth in the corneal zone. As to which of the two lenses is being assessed, both the investigator and the participant will be masked as the assistant will provide the lenses in an unlabeled case. Masking the investigator will prevent bias when measuring corneal thickness and analyzing the data. The objectives of this study are to take a sample of keratoconic and control participants, fit them in scleral lenses, and to measure topographic corneal thickness after 8-10 hours of scleral lens wear after three weeks of wear, to compare two instruments in the measurement of corneal thickness, and to compare the effects of varying central corneal clearance of the scleral lens on corneal thickness. Secondary objectives include comparing ocular physiological outcomes between the two test lens designs. Corneal thickness will be altered post scleral lens wear compared to pre-lens wear and the amount of alteration will correlate to the fitting characteristics in the central zone of the scleral lenses.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Keratoconics wearing ZenLens with high central clearance
Scleral contact lenses designed to provide approximately 450 microns of central clearance.
ZenLens™
The ZenLens™ semi-scleral lenses are manufactured by Alden Optic Laboratories Inc., Lancaster, NY. They will be made in Boston XO material.
Keratoconics wearing ZenLens with low central clearance
Scleral contact lenses designed to provide approximately 350 microns of central clearance.
ZenLens™
The ZenLens™ semi-scleral lenses are manufactured by Alden Optic Laboratories Inc., Lancaster, NY. They will be made in Boston XO material.
Healthy controls wearing ZenLens with high central clearance
Scleral contact lenses designed to provide approximately 450 microns of central clearance.
Zen™ RC
The Zen™ RC semi-scleral lenses are manufactured by Alden Optic Laboratories Inc., Lancaster, NY. They will be made in Boston XO material.
Healthy controls wearing ZenLens with low central clearance
Scleral contact lenses designed to provide approximately 350 microns of central clearance.
Zen™ RC
The Zen™ RC semi-scleral lenses are manufactured by Alden Optic Laboratories Inc., Lancaster, NY. They will be made in Boston XO material.
Interventions
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ZenLens™
The ZenLens™ semi-scleral lenses are manufactured by Alden Optic Laboratories Inc., Lancaster, NY. They will be made in Boston XO material.
Zen™ RC
The Zen™ RC semi-scleral lenses are manufactured by Alden Optic Laboratories Inc., Lancaster, NY. They will be made in Boston XO material.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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.
* 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.
18 Years
ALL
Yes
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
University of Waterloo
OTHER
Responsible Party
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Luigina Sorbara
Associate Professor
Principal Investigators
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Luigina Sorbara, OD MSc
Role: PRINCIPAL_INVESTIGATOR
University of Waterloo
Locations
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University of Waterloo School of Optometry and Vision Science
Waterloo, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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van der Worp E, Bornman D, Ferreira DL, Faria-Ribeiro M, Garcia-Porta N, Gonzalez-Meijome JM. Modern scleral contact lenses: A review. Cont Lens Anterior Eye. 2014 Aug;37(4):240-50. doi: 10.1016/j.clae.2014.02.002. Epub 2014 Mar 12.
Romero-Rangel T, Stavrou P, Cotter J, Rosenthal P, Baltatzis S, Foster CS. Gas-permeable scleral contact lens therapy in ocular surface disease. Am J Ophthalmol. 2000 Jul;130(1):25-32. doi: 10.1016/s0002-9394(00)00378-0.
Walker MK, Bergmanson JP, Miller WL, Marsack JD, Johnson LA. Complications and fitting challenges associated with scleral contact lenses: A review. Cont Lens Anterior Eye. 2016 Apr;39(2):88-96. doi: 10.1016/j.clae.2015.08.003. Epub 2015 Sep 2.
Ucakhan OO, Ozkan M, Kanpolat A. Corneal thickness measurements in normal and keratoconic eyes: Pentacam comprehensive eye scanner versus noncontact specular microscopy and ultrasound pachymetry. J Cataract Refract Surg. 2006 Jun;32(6):970-7. doi: 10.1016/j.jcrs.2006.02.037.
Liesegang TJ. Contact lens-related microbial keratitis: Part I: Epidemiology. Cornea. 1997 Mar;16(2):125-31.
Other Identifiers
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22186
Identifier Type: -
Identifier Source: org_study_id
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