Lag of Accommodation With DOT Spectacle Lenses

NCT04700111 | Active Not Recruiting FDA Device

• 1 other identifier: CPRO-2011-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to measure the difference in the lag of accommodation between DOT spectacle lenses and control spectacles.

Conditions

Myopia, Myopia Progression, Lag of Accommodation, Hyperopic Retinal Blur, Reduction in Contrast

Outcome Measures

Primary Outcomes (1)

• Best vision sphere

  1\) Autorefractor spherical equivalent refraction measured at distance and at 40cm with each pair of treatment spectacles

  90 minutes

Study Arms (2)

Treatment 1 - DOT Pattern

EXPERIMENTAL

Spectacle lens or treatment 1

Device: DOT Pattern

Treatment 2 - Control Spectacles

ACTIVE COMPARATOR

Comparator lens or control arm

Device: Control Spectacles

Interventions

DOT Pattern DEVICE

DOT Pattern Spectacle Lens

Treatment 1 - DOT Pattern

Control Spectacles DEVICE

Control lens

Treatment 2 - Control Spectacles

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

A person is eligible for inclusion in the study if he/she: 1. Age 6-18 years of age, with a maximum of 6 of the first 25 completed participants being older than 14 years of age. 2. 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. 3. 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. 4. Should be emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D. 5. Is willing and able to follow instructions. A person will be excluded from the study if he/she: 1. Is participating in any concurrent clinical or research study. 2. Have a history of myopia control treatment in the past year. 3. Has amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency. 4. Has any known active ocular disease and/or infection. 5. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism. 6. 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. 7. Has undergone strabismus surgery, refractive error surgery or intraocular surgery. 8. Is a child of a member of the study team.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SightGlass Vision, Inc.: lead
• University of Waterloo: collaborator

Study Sites (1)

Centre for Ocular Research and Education

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 7, 2021
• Study Start: February 1, 2022
• Primary Completion: June 9, 2022
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CA (1)