Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness (ASH-2)

Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness and Choroidal Vascularity Index in Emmetropes

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia; Myopia Progression; Juvenile Myopia
• Intervention / Treatment: Device: Diffusion Optics Technology (DOT) Pattern Spectacle Lens; Device: Control Spectacle Lens

• Study Type: Interventional
• Enrollment (Estimated): 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: 8 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

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 - Diffusion Optics Technology (DOT) Pattern	Device: Diffusion Optics Technology (DOT) Pattern Spectacle Lens; DOT Pattern Spectacle Lens
Active Comparator: Treatment 2 - Control Spectacles	Device: Control Spectacle Lens; Control Spectacles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Software Method Comparison	Comparison of measurements using different software methods; manual, semiautomated and automated software	30 minutes and 60 minutes

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Actual): April 30, 2023
• Study Completion (Estimated): May 15, 2024

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CPRO-2207-001

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