Effect of Colour Temperature of Reading Lamp on Refractive Error Development

Sponsor

The Hong Kong Polytechnic University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05733182

Collaborator

(none)

798

Enrollment

Location

Arms

Anticipated Duration (Months)

13.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors	Device: 3000K Reading lamp Device: 4500K Reading lamp Device: 6500K Reading lamp	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

798 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized clinical trialRandomized clinical trial

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

Effect of Colour Temperature of Reading Lamp on Refractive Error Development

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Jun 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 3000K Participants will receive a reading lamp of colour temperature 3000K.	Device: 3000K Reading lamp Reading lamp with custom-made circuitry to emit light of 3000K colour temperature
Active Comparator: 4500K Participants will receive a reading lamp of colour temperature 4500K.	Device: 4500K Reading lamp Reading lamp with custom-made circuitry to emit light of 4500K colour temperature
Active Comparator: 6500K Participants will receive a reading lamp of colour temperature 6500K.	Device: 6500K Reading lamp Reading lamp with custom-made circuitry to emit light of 6500K colour temperature

Arm

Intervention/Treatment

Active Comparator: 3000K

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

Device: 3000K Reading lamp

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

Active Comparator: 4500K

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

Device: 4500K Reading lamp

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

Active Comparator: 6500K

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

Device: 6500K Reading lamp

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

Outcome Measures

Primary Outcome Measures

Cycloplegic refraction [up to 12 months]
Refractive error in diopter by autorefractor
Axial length [up to 12 months]
Length of the eyeball in millimeter by partial coherence interferometer

Secondary Outcome Measures

Colour vision [up to 12 months]
Ability to distinguish colours (pass/fail & severity of defect) measured by pseudoisochromatic plates

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

aged between 4 and 18 years

Exclusion Criteria:

have received myopia control intervention

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Optometry Research Clinic	Hong Kong	Kowloon	Hong Kong	000000

Sponsors and Collaborators

The Hong Kong Polytechnic University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr CHOI Kai Yip, Research Assistant Professor, The Hong Kong Polytechnic University

ClinicalTrials.gov Identifier:

NCT05733182

Other Study ID Numbers:

00000

First Posted:

Feb 17, 2023

Last Update Posted:

Feb 17, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr CHOI Kai Yip, Research Assistant Professor, The Hong Kong Polytechnic University

Additional relevant MeSH terms:

Refractive Errors

Study Results

No Results Posted as of Feb 17, 2023