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Lag of Accommodation With DOT Spectacle Lenses (ASH)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
DOT Pattern
Control Spectacles
Sponsored by
SightGlass Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia, Myopia Progression, Lag of Accommodation, Hyperopic Retinal Blur, Reduction in Contrast

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Centre for Ocular Research and Education

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment 1 - DOT Pattern

Treatment 2 - Control Spectacles

Arm Description

Spectacle lens or treatment 1

Comparator lens or control arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 6, 2021
Last Updated
April 10, 2023
Sponsor
SightGlass Vision, Inc.
Collaborators
University of Waterloo
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1. Study Identification

Unique Protocol Identification Number
NCT04700111
Brief Title
Lag of Accommodation With DOT Spectacle Lenses
Acronym
ASH
Official Title
Lag of Accommodation With DOT Spectacle Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
June 9, 2022 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SightGlass Vision, Inc.
Collaborators
University of Waterloo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Myopia Progression, Lag of Accommodation, Hyperopic Retinal Blur, Reduction in Contrast

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment 1 - DOT Pattern
Arm Type
Experimental
Arm Description
Spectacle lens or treatment 1
Arm Title
Treatment 2 - Control Spectacles
Arm Type
Active Comparator
Arm Description
Comparator lens or control arm
Intervention Type
Device
Intervention Name(s)
DOT Pattern
Intervention Description
DOT Pattern Spectacle Lens
Intervention Type
Device
Intervention Name(s)
Control Spectacles
Intervention Description
Control lens
Primary Outcome Measure Information:
Title
Best vision sphere
Description
1) Autorefractor spherical equivalent refraction measured at distance and at 40cm with each pair of treatment spectacles
Time Frame
90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
A person is eligible for inclusion in the study if he/she: Age 6-18 years of age, with a maximum of 6 of the first 25 completed participants being older than 14 years of age. 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. 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. Should be emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D. Is willing and able to follow instructions. A person will be excluded from the study if he/she: Is participating in any concurrent clinical or research study. Have a history of myopia control treatment in the past year. Has amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency. Has any known active ocular disease and/or infection. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism. 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. Has undergone strabismus surgery, refractive error surgery or intraocular surgery. Is a child of a member of the study team.
Facility Information:
Facility Name
Centre for Ocular Research and Education
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Lag of Accommodation With DOT Spectacle Lenses

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