Lag of Accommodation With DOT Spectacle Lenses

Myopia, Myopia Progression, Lag of Accommodation, Hyperopic Retinal Blur, Reduction in Contrast Clinical Trial

— ASH  

Official title:

Lag of Accommodation With DOT Spectacle Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04700111
• Other study ID #: CPRO-2011-001
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: January 30, 2023

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 difference in the lag of accommodation between DOT spectacle lenses and control spectacles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 30, 2023
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• DOT Pattern
DOT Pattern Spectacle Lens
• Control Spectacles
Control lens

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	Best vision sphere	1) Autorefractor spherical equivalent refraction measured at distance and at 40cm with each pair of treatment spectacles	90 minutes