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ASH: Lag of Accommodation With DOT Spectacle Lenses

Sponsor
SightGlass Vision, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04700111
Collaborator
University of Waterloo (Other)
75
Enrollment
1
Location
2
Arms
7.8
Anticipated Duration (Months)
9.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: DOT Pattern
  • Device: Control Spectacles
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Lag of Accommodation With DOT Spectacle Lenses
Anticipated Study Start Date :
Jan 5, 2022
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment 1 - DOT Pattern

Spectacle lens or treatment 1

Device: DOT Pattern
DOT Pattern Spectacle Lens
Active Comparator: Treatment 2 - Control Spectacles

Comparator lens or control arm

Device: Control Spectacles
Control lens

Outcome Measures

Primary Outcome Measures

  1. Best vision sphere [90 minutes]

    1) Autorefractor spherical equivalent refraction measured at distance and at 40cm with each pair of treatment spectacles

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre for Ocular Research and Education Waterloo Ontario Canada N2L 3G1

Sponsors and Collaborators

  • SightGlass Vision, Inc.
  • University of Waterloo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SightGlass Vision, Inc.
ClinicalTrials.gov Identifier:
NCT04700111
Other Study ID Numbers:
  • CPRO-2011-001
First Posted:
Jan 7, 2021
Last Update Posted:
Jan 11, 2022
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Myopia

Study Results

No Results Posted as of Jan 11, 2022