NCT05733182

Brief Summary

This is a 12-month longitudinal randomized controlled trial aiming to evaluate the effect of colour temperature of reading lamp on refractive error development.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
798

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Jul 2022Jun 2027

Study Start

First participant enrolled

July 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Expected
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

February 6, 2023

Last Update Submit

February 28, 2024

Conditions

Refractive Errors

Keywords

MyopiaEnvironmentColour temperatureLighting

Outcome Measures

Primary Outcomes (2)

  • Cycloplegic refraction

    Refractive error in diopter by autorefractor

    up to 12 months

  • Axial length

    Length of the eyeball in millimeter by partial coherence interferometer

    up to 12 months

Secondary Outcomes (1)

  • Colour vision

    up to 12 months

Study Arms (3)

3000K

ACTIVE COMPARATOR

Participants will receive a reading lamp of colour temperature 3000K.

Device: 3000K Reading lamp

4500K

ACTIVE COMPARATOR

Participants will receive a reading lamp of colour temperature 4500K.

Device: 4500K Reading lamp

6500K

ACTIVE COMPARATOR

Participants will receive a reading lamp of colour temperature 6500K.

Device: 6500K Reading lamp

Interventions

3000K Reading lampDEVICE

Reading lamp with custom-made circuitry to emit light of 3000K colour temperature

3000K
4500K Reading lampDEVICE

Reading lamp with custom-made circuitry to emit light of 4500K colour temperature

4500K
6500K Reading lampDEVICE

Reading lamp with custom-made circuitry to emit light of 6500K colour temperature

6500K

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • aged between 4 and 18 years

You may not qualify if:

  • have received myopia control intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Optometry Research Clinic

Hong Kong, Kowloon, 000000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Refractive ErrorsMyopia

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Kai Yip Choi, PhD

CONTACT

(852)34002934kaiyip.choi@polyu.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 17, 2023

Study Start

July 1, 2022

Primary Completion

June 30, 2025

Study Completion (Estimated)

June 30, 2027

Last Updated

March 1, 2024

Record last verified: 2024-02

Locations

HK(1)