Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness

NCT05617794 | Active Not Recruiting FDA Device

• 1 other identifier: CPRO-2207-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to measure the effect of Diffusion Optics Technology (DOT) spectacle lenses on the choroidal thickness and choroidal vascularity index compared to control lenses.

Conditions

Myopia; Myopia Progression; Juvenile Myopia

Outcome Measures

Primary Outcomes (2)

• Choroidal Thickness

  Change from Baseline, 30 minutes and 60 minutes

  30 minutes and 60 minutes

• Retinal and Choroidal Thickness

  Change from Baseline, 30 minutes and 60 minutes

  30 minutes and 60 minutes

Secondary Outcomes (1)

• Software Method Comparison

  30 minutes and 60 minutes

Study Arms (2)

Treatment 1 - Diffusion Optics Technology (DOT) Pattern

EXPERIMENTAL

Device: Diffusion Optics Technology (DOT) Pattern Spectacle Lens

Treatment 2 - Control Spectacles

ACTIVE COMPARATOR

Device: Control Spectacle Lens

Interventions

Control Spectacle Lens DEVICE

Control Spectacles

Treatment 2 - Control Spectacles

Diffusion Optics Technology (DOT) Pattern Spectacle Lens DEVICE

DOT Pattern Spectacle Lens

Treatment 1 - Diffusion Optics Technology (DOT) Pattern

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Are 8-14 years of age;
• Are able to read (or be read to), understand and sign the assent document;
• Are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document;
• Are emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D inclusively;
• Are willing and able to follow instructions.

You may not qualify if:

• Are participating in any concurrent interventional clinical or research study;
• Have a history of myopia control treatment in the past year;
• Have amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency;
• Have any known active ocular disease and/or infection;
• Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism;
• Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include Atropine eye drops;
• Have undergone strabismus surgery, refractive error surgery or intraocular surgery;
• Are a child of a member of the study team.

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: November 1, 2022
• First Posted: November 15, 2022
• Study Start: January 18, 2023
• Primary Completion: April 30, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CA (1)