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

Myopia Clinical Trial

— ASH-2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05617794
• Other study ID #: CPRO-2207-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 18, 2023
• Est. completion date: May 15, 2024

Study information

• Verified date: December 2023
• Source: SightGlass Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 15, 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Juvenile Myopia
• Myopia
• Myopia Progression

Intervention

Device:
• Diffusion Optics Technology (DOT) Pattern Spectacle Lens
DOT Pattern Spectacle Lens
• Control Spectacle Lens
Control Spectacles

Locations

Country	Name	City	State
Canada	Centre for Ocular Research and Education	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
SightGlass Vision, Inc.	University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Choroidal Thickness	Change from Baseline, 30 minutes and 60 minutes	30 minutes and 60 minutes
Primary	Retinal and Choroidal Thickness	Change from Baseline, 30 minutes and 60 minutes	30 minutes and 60 minutes
Secondary	Software Method Comparison	Comparison of measurements using different software methods; manual, semiautomated and automated software	30 minutes and 60 minutes