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Contact Lens

Keratoconics wearing ZenLens with high central clearance for Keratoconus

N/A
Waitlist Available
Led By Luigina Sorbara, OD MSc
Research Sponsored by University of Waterloo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Had been diagnosed with keratoconus in at least one eye.
Is at least 18 years of age and has full legal capacity to volunteer.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study Summary

This trial is investigating whether scleral contact lenses cause corneal thickness to change in people with keratoconus, and whether this change is associated with low levels of corneal hypoxia.

Eligible Conditions
  • Keratoconus
  • Healthy Controls

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Corneal Thickness
Secondary outcome measures
Conjunctival redness
Corneal and conjunctival staining
Tear biochemistry: cell count
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Keratoconics wearing ZenLens with low central clearanceExperimental Treatment1 Intervention
Scleral contact lenses designed to provide approximately 350 microns of central clearance.
Group II: Keratoconics wearing ZenLens with high central clearanceExperimental Treatment1 Intervention
Scleral contact lenses designed to provide approximately 450 microns of central clearance.
Group III: Healthy controls wearing ZenLens with high central clearanceActive Control1 Intervention
Scleral contact lenses designed to provide approximately 450 microns of central clearance.
Group IV: Healthy controls wearing ZenLens with low central clearanceActive Control1 Intervention
Scleral contact lenses designed to provide approximately 350 microns of central clearance.

Find a Location

Who is running the clinical trial?

University of WaterlooLead Sponsor
123 Previous Clinical Trials
209,738 Total Patients Enrolled
2 Trials studying Keratoconus
21 Patients Enrolled for Keratoconus
Bausch & Lomb IncorporatedIndustry Sponsor
251 Previous Clinical Trials
57,375 Total Patients Enrolled
2 Trials studying Keratoconus
25 Patients Enrolled for Keratoconus
Luigina Sorbara, OD MScPrincipal InvestigatorUniversity of Waterloo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
University of Waterloo School of Optometry and Vision Science
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am interested on improving my -20 vision.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Corneal Thickness Changes With Scleral Contact Lenses
Luigina Sorbara 2017. "Corneal Thickness Changes With Scleral Contact Lenses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03249233.
All > Intraocular Lens
~5 spots leftby Apr 2025
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