NCT03538002

Brief Summary

The purpose of this study is to investigate if the blue-light filtering spectacle lenses promote myopia progression in schoolchildren.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 15, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

September 10, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

January 13, 2022

Status Verified

January 1, 2021

Enrollment Period

3.2 years

First QC Date

May 15, 2018

Last Update Submit

January 12, 2022

Conditions

Myopia

Keywords

blue light filtering spectacle lens

Outcome Measures

Primary Outcomes (1)

  • Cycloplegic refraction

    Refraction done under cycloplegia

    2 years

Secondary Outcomes (1)

  • Axial length

    2 years

Study Arms (2)

Conventional anti-reflection coated spectacle lens

NO INTERVENTION

Single vision lenses with correction of distant refraction and conventional anti-reflection coating

Blue-light filtering spectacle lenses

EXPERIMENTAL

Single vision lenses with correction of distant refraction and blue-light filtering coating

Device: Blue-light filtering spectacle lenses

Interventions

Blue-light filtering spectacle lensesDEVICE

This is a single vision spectacle lens for correction of distant refractions and filtering out the blue light by providing anti-blue light coating.

Blue-light filtering spectacle lenses

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Refraction: myopia of -1.00 dioptres (D) to -5.00D
  • Astigmatism: equal or less than -1.50D
  • Anisometropia: equal or less than 1.00D
  • Best corrected monocular visual acuity: 0.0 LogMAR or better after full correction
  • Parents' understanding and acceptance of random allocation of grouping

You may not qualify if:

  • any ocular and systemic abnormalities might affect visual functions or refractive development
  • prior treatment of myopic control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre of Myopia Research, School of Optometry, The Hong Kong Polytechnic University

Hong Kong, 00000, Hong Kong

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Ka Man Chun, PhD

    Centre for Myopia Research, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2018

First Posted

May 25, 2018

Study Start

September 10, 2018

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

January 13, 2022

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)