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

SightGlass Vision

Status

Active, not recruiting

Conditions

Myopia

Myopia Progression

Juvenile Myopia

Treatments

Device: Diffusion Optics Technology (DOT) Pattern Spectacle Lens

Device: Control Spectacle Lens

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05617794

CPRO-2207-001

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

8 to 14 years old

Volunteers

Accepts 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.