search
Back to results

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

Primary Purpose

Myopia, Myopia Progression, Juvenile Myopia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Diffusion Optics Technology (DOT) Pattern Spectacle Lens
Control Spectacle Lens
Sponsored by
SightGlass Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

8 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Centre for Ocular Research and EducationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment 1 - Diffusion Optics Technology (DOT) Pattern

Treatment 2 - Control Spectacles

Arm Description

Outcomes

Primary Outcome Measures

Choroidal Thickness
Change from Baseline, 30 minutes and 60 minutes
Retinal and Choroidal Thickness
Change from Baseline, 30 minutes and 60 minutes

Secondary Outcome Measures

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

Full Information

First Posted
November 1, 2022
Last Updated
April 10, 2023
Sponsor
SightGlass Vision, Inc.
Collaborators
University of Waterloo
search

1. Study Identification

Unique Protocol Identification Number
NCT05617794
Brief Title
Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness
Acronym
ASH-2
Official Title
Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness and Choroidal Vascularity Index in Emmetropes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
May 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SightGlass Vision, Inc.
Collaborators
University of Waterloo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Myopia Progression, Juvenile Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment 1 - Diffusion Optics Technology (DOT) Pattern
Arm Type
Experimental
Arm Title
Treatment 2 - Control Spectacles
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Diffusion Optics Technology (DOT) Pattern Spectacle Lens
Intervention Description
DOT Pattern Spectacle Lens
Intervention Type
Device
Intervention Name(s)
Control Spectacle Lens
Intervention Description
Control Spectacles
Primary Outcome Measure Information:
Title
Choroidal Thickness
Description
Change from Baseline, 30 minutes and 60 minutes
Time Frame
30 minutes and 60 minutes
Title
Retinal and Choroidal Thickness
Description
Change from Baseline, 30 minutes and 60 minutes
Time Frame
30 minutes and 60 minutes
Secondary Outcome Measure Information:
Title
Software Method Comparison
Description
Comparison of measurements using different software methods; manual, semiautomated and automated software
Time Frame
30 minutes and 60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Woods
Phone
1 519-888-4567
Email
jwoods@uwaterloo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Asiya Jabeen
Phone
1 519-888-4567
Email
ajabeen@uwaterloo.ca
Facility Information:
Facility Name
Centre for Ocular Research and Education
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asiya Jabeen
Phone
+1 519-888-4567
Email
ajabeen@uwaterloo.ca
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD, FCOptom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs