Status:
ACTIVE_NOT_RECRUITING
Lag of Accommodation With DOT Spectacle Lenses
Lead Sponsor:
SightGlass Vision, Inc.
Collaborating Sponsors:
University of Waterloo
Conditions:
Myopia, Myopia Progression, Lag of Accommodation, Hyperopic Retinal Blur, Reduction in Contrast
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
The objective of the study is to measure the difference in the lag of accommodation between DOT spectacle lenses and control spectacles.
Eligibility Criteria
Inclusion
- A person is eligible for inclusion in the study if he/she:
- Age 6-18 years of age, with a maximum of 6 of the first 25 completed participants being older than 14 years of age.
- Is able to read (or be read to), understand and sign the assent document if under 17 years old or is able to read, understand and sign the consent document if aged 17 or 18 years.
- Is under 17 years old and is accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document.
- Should be emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D.
- Is willing and able to follow instructions.
- A person will be excluded from the study if he/she:
- Is participating in any concurrent clinical or research study.
- Have a history of myopia control treatment in the past year.
- Has amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency.
- Has any known active ocular disease and/or infection.
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism.
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include Atropine eye drops.
- Has undergone strabismus surgery, refractive error surgery or intraocular surgery.
- Is a child of a member of the study team.
Exclusion
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04700111
Start Date
February 1 2022
End Date
March 31 2026
Last Update
December 20 2024
Active Locations (1)
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1
Centre for Ocular Research and Education
Waterloo, Ontario, Canada, N2L 3G1