Lag of Accommodation With DOT Spectacle Lenses (ASH)

SightGlass Vision

Status: Active, not recruiting

Conditions: Myopia, Myopia Progression, Lag of Accommodation, Hyperopic Retinal Blur, Reduction in Contrast

Treatments: Device: DOT Pattern; Device: Control Spectacles

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04700111

CPRO-2011-001

Details and patient eligibility

About

The objective of the study is to measure the difference in the lag of accommodation between DOT spectacle lenses and control spectacles.

Enrollment: 30 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

A person is eligible for inclusion in the study if he/she:

1. Age 6-18 years of age, with a maximum of 6 of the first 25 completed participants being older than 14 years of age.
2. Is able to read (or be read to), understand and sign the assent document if under 17 years old or is able to read, understand and sign the consent document if aged 17 or 18 years.
3. Is under 17 years old and is accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document.
4. Should be emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D.
5. Is willing and able to follow instructions.

A person will be excluded from the study if he/she:

1. Is participating in any concurrent clinical or research study.
2. Have a history of myopia control treatment in the past year.
3. Has amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency.
4. Has any known active ocular disease and/or infection.
5. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism.
6. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include Atropine eye drops.
7. Has undergone strabismus surgery, refractive error surgery or intraocular surgery.
8. Is a child of a member of the study team.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Treatment 1 - DOT Pattern

Experimental group

Description:

Spectacle lens or treatment 1

Treatment:

Device: DOT Pattern

Treatment 2 - Control Spectacles

Active Comparator group

Description:

Comparator lens or control arm

Treatment:

Device: Control Spectacles