Lag of Accommodation With DOT Spectacle Lenses (ASH)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia, Myopia Progression, Lag of Accommodation, Hyperopic Retinal Blur, Reduction in Contrast
• Intervention / Treatment: Device: DOT Pattern; Device: Control Spectacles

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Ocular Research and Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment 1 - DOT Pattern; Spectacle lens or treatment 1	Device: DOT Pattern; DOT Pattern Spectacle Lens
Active Comparator: Treatment 2 - Control Spectacles; Comparator lens or control arm	Device: Control Spectacles; Control lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best vision sphere	1) Autorefractor spherical equivalent refraction measured at distance and at 40cm with each pair of treatment spectacles	90 minutes

Collaborators and Investigators

• Sponsor: SightGlass Vision, Inc.
• Collaborators: University of Waterloo

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): June 9, 2022
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CPRO-2011-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes