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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05733182
Other study ID # 00000
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date June 30, 2027

Study information

Verified date February 2024
Source The Hong Kong Polytechnic University
Contact Kai Yip Choi, PhD
Phone (852)34002934
Email kaiyip.choi@polyu.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 798
Est. completion date June 30, 2027
Est. primary completion date June 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 18 Years
Eligibility Inclusion Criteria: - aged between 4 and 18 years Exclusion Criteria: - have received myopia control intervention

Study Design


Related Conditions & MeSH terms


Intervention

Device:
3000K Reading lamp
Reading lamp with custom-made circuitry to emit light of 3000K colour temperature
4500K Reading lamp
Reading lamp with custom-made circuitry to emit light of 4500K colour temperature
6500K Reading lamp
Reading lamp with custom-made circuitry to emit light of 6500K colour temperature

Locations

Country Name City State
Hong Kong Optometry Research Clinic Hong Kong Kowloon

Sponsors (1)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cycloplegic refraction Refractive error in diopter by autorefractor up to 12 months
Primary Axial length Length of the eyeball in millimeter by partial coherence interferometer up to 12 months
Secondary Colour vision Ability to distinguish colours (pass/fail & severity of defect) measured by pseudoisochromatic plates up to 12 months
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