NCT03818880

Brief Summary

Diurnal variations in the thickness of the choroid have been reported in the literature, and, more recently, the role of the choroid has been studied with respect to its role in myopia (near-sightedness) progression.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Dec 2018Dec 2026

Study Start

First participant enrolled

December 18, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2022

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

January 23, 2019

Last Update Submit

April 29, 2026

Conditions

Myopia, Progressive

Keywords

MyopiaMyopia control

Outcome Measures

Primary Outcomes (1)

  • Choroidal thickness

    Measurement of choroidal thickness by Triton optical coherence tomographer (OCT), including post-imaging analysis

    3 years

Secondary Outcomes (1)

  • Visual field

    3 years

Study Arms (1)

Treatment

EXPERIMENTAL

Subjects wearing novel spectacle lenses will be assessed

Device: Novel spectacle lens design

Interventions

Novel spectacle lens designDEVICE

Spectacle lens to control progression of myopia

Treatment

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participating in the CPRO-1802-001 (Cypress\_SG) study at CORE
  • Read and signed an Assent and their parent/guardian has signed an information consent letter

You may not qualify if:

  • Transient health condition which may affect the eye(s) (e.g. a common cold, active allergies, fatigue, etc;)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Ocular Research and Education

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia, DegenerativeMyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Lyndon Jones, PhD, FCOptom

    Centre for Ocular Research & Education, Canada

    PRINCIPAL INVESTIGATOR

  • Jill Woods, BSc, MCOptom

    Centre for Ocular Research & Education, Canada

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2019

First Posted

January 28, 2019

Study Start

December 18, 2018

Primary Completion

April 21, 2022

Study Completion (Estimated)

December 31, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations

CA(1)