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OpenTrials
Active, Not Recruiting

NCT Number: NCT05617794

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Ocular Research and Education

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diffusion Optics Technology (DOT) Pattern Spectacle Lens

Device

DOT Pattern Spectacle Lens

Control Spectacle Lens

Device

Control Spectacles

Primary outcomes

  1. Choroidal Thickness

    Time frame: 30 minutes and 60 minutes

    Change from Baseline, 30 minutes and 60 minutes

  2. Retinal and Choroidal Thickness

    Time frame: 30 minutes and 60 minutes

    Change from Baseline, 30 minutes and 60 minutes

Secondary outcomes

  1. Software Method Comparison

    Time frame: 30 minutes and 60 minutes

    Comparison of measurements using different software methods; manual, semiautomated and automated software

Sponsors and collaborators

Lead sponsor

SightGlass Vision, Inc.

Industry

Collaborators

  • University of Waterloo

Registry information

Official study title

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

Acronym: ASH-2

Important dates

Study start
2023
Primary completion
2023
Study completion
2026
First posted
Nov 15, 2022
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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