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Effect of Colour Temperature of Reading Lamp on Refractive Error Development

Primary Purpose

Refractive Errors

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
3000K Reading lamp
4500K Reading lamp
6500K Reading lamp
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Refractive Errors focused on measuring Myopia, Environment, Colour temperature, Lighting

Eligibility Criteria

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

Inclusion Criteria: aged between 4 and 18 years Exclusion Criteria: have received myopia control intervention

Sites / Locations

  • Optometry Research ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

3000K

4500K

6500K

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Cycloplegic refraction
Refractive error in diopter by autorefractor
Axial length
Length of the eyeball in millimeter by partial coherence interferometer

Secondary Outcome Measures

Colour vision
Ability to distinguish colours (pass/fail & severity of defect) measured by pseudoisochromatic plates

Full Information

First Posted
February 6, 2023
Last Updated
February 14, 2023
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT05733182
Brief Title
Effect of Colour Temperature of Reading Lamp on Refractive Error Development
Official Title
Effect of Colour Temperature of Reading Lamp on Refractive Error Development
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Myopia has reached epidemic in the world, especially in East Asia. The proportion of myopic population increases drastically during schoolage. Lack of light exposure has been suggested to be a risk for myopia development, in which additional reading lamp may alleviate this condition. However, the effect of colour temperature of the reading lamp is unknown on childhood refractive error development. In this study, investigators will randomly allocate school-aged children into groups, who will receive reading lamps of different colour temperatures for their daily use. The participants' refractive error and axial length will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
Keywords
Myopia, Environment, Colour temperature, Lighting

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
798 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3000K
Arm Type
Active Comparator
Arm Description
Participants will receive a reading lamp of colour temperature 3000K.
Arm Title
4500K
Arm Type
Active Comparator
Arm Description
Participants will receive a reading lamp of colour temperature 4500K.
Arm Title
6500K
Arm Type
Active Comparator
Arm Description
Participants will receive a reading lamp of colour temperature 6500K.
Intervention Type
Device
Intervention Name(s)
3000K Reading lamp
Intervention Description
Reading lamp with custom-made circuitry to emit light of 3000K colour temperature
Intervention Type
Device
Intervention Name(s)
4500K Reading lamp
Intervention Description
Reading lamp with custom-made circuitry to emit light of 4500K colour temperature
Intervention Type
Device
Intervention Name(s)
6500K Reading lamp
Intervention Description
Reading lamp with custom-made circuitry to emit light of 6500K colour temperature
Primary Outcome Measure Information:
Title
Cycloplegic refraction
Description
Refractive error in diopter by autorefractor
Time Frame
up to 12 months
Title
Axial length
Description
Length of the eyeball in millimeter by partial coherence interferometer
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Colour vision
Description
Ability to distinguish colours (pass/fail & severity of defect) measured by pseudoisochromatic plates
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: aged between 4 and 18 years Exclusion Criteria: have received myopia control intervention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Yip Choi, PhD
Phone
(852)34002934
Email
kaiyip.choi@polyu.edu.hk
Facility Information:
Facility Name
Optometry Research Clinic
City
Hong Kong
State/Province
Kowloon
ZIP/Postal Code
000000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Yip Choi, PhD
Phone
(852)34002934
Email
kaiyip.choi@polyu.edu.hk

12. IPD Sharing Statement

Learn more about this trial

Effect of Colour Temperature of Reading Lamp on Refractive Error Development

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