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

Not Applicable

Active, not recruiting

• Conditions: Myopia; Myopia Progression; Juvenile Myopia
• Interventions: Device: Diffusion Optics Technology (DOT) Pattern Spectacle Lens; Device: Control Spectacle Lens

• Registration Number: NCT05617794
• Lead Sponsor: SightGlass Vision, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-11
• Study First Posted: 2022-11-15
• Study Start: 2023-01-18
• Primary Completion: 2023-04-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment 1 - Diffusion Optics Technology (DOT) Pattern	Diffusion Optics Technology (DOT) Pattern Spectacle Lens	-
Treatment 2 - Control Spectacles	Control Spectacle Lens	-

Primary Outcome Measures

Name	Time	Method
Retinal and Choroidal Thickness	30 minutes and 60 minutes	Change from Baseline, 30 minutes and 60 minutes
Choroidal Thickness	30 minutes and 60 minutes	Change from Baseline, 30 minutes and 60 minutes

Secondary Outcome Measures

Name	Time	Method
Software Method Comparison	30 minutes and 60 minutes	Comparison of measurements using different software methods; manual, semiautomated and automated software

Trial Locations

Locations (1)

Centre for Ocular Research and Education; 🇨🇦 Waterloo, Ontario, Canada