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

Sponsor
SightGlass Vision, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05617794
Collaborator
University of Waterloo (Other)
30
1
2
4.3
7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Diffusion Optics Technology (DOT) Pattern Spectacle Lens
  • Device: Control Spectacle Lens
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness and Choroidal Vascularity Index in Emmetropes
Anticipated Study Start Date :
Dec 5, 2022
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Apr 15, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Choroidal Thickness [30 minutes and 60 minutes]

    Change from Baseline, 30 minutes and 60 minutes

  2. Retinal and Choroidal Thickness [30 minutes and 60 minutes]

    Change from Baseline, 30 minutes and 60 minutes

Secondary Outcome Measures

  1. Software Method Comparison [30 minutes and 60 minutes]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 14 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre for Ocular Research and Education Waterloo Ontario Canada N2L 3G1

Sponsors and Collaborators

  • SightGlass Vision, Inc.
  • University of Waterloo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SightGlass Vision, Inc.
ClinicalTrials.gov Identifier:
NCT05617794
Other Study ID Numbers:
  • CPRO-2207-001
First Posted:
Nov 15, 2022
Last Update Posted:
Dec 8, 2022
Last Verified:
Nov 1, 2022
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 8, 2022