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

Last updated: December 18, 2024
Sponsor: SightGlass Vision, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Myopia

Treatment

Control Spectacle Lens

Diffusion Optics Technology (DOT) Pattern Spectacle Lens

Clinical Study ID

NCT05617794
CPRO-2207-001
  • Ages 8-14
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 andsign the parental information and permission document;

  • Are emmetropic by non-cycloplegic auto-refraction, which means both refractivemeridians should be within +1.00D and -1.00D inclusively;

  • Are willing and able to follow instructions.

Exclusion

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 studyoutcome variable. Examples include diabetes mellitus, hyperthyroidism;

  • Are using any systemic or topical medications that in the opinion of theinvestigator may affect a study outcome variable. Examples include Atropine eyedrops;

  • Have undergone strabismus surgery, refractive error surgery or intraocular surgery;

  • Are a child of a member of the study team.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Control Spectacle Lens
Phase:
Study Start date:
January 18, 2023
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Centre for Ocular Research and Education

    Waterloo, Ontario N2L 3G1
    Canada

    Site Not Available

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