- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05733182
Effect of Colour Temperature of Reading Lamp on Refractive Error Development
February 28, 2024 updated by: Dr CHOI Kai Yip, The Hong Kong Polytechnic University
This is a 12-month longitudinal randomized controlled trial aiming to evaluate the effect of colour temperature of reading lamp on refractive error development.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
798
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kai Yip Choi, PhD
- Phone Number: (852)34002934
- Email: kaiyip.choi@polyu.edu.hk
Study Locations
-
-
Kowloon
-
Hong Kong, Kowloon, Hong Kong, 000000
- Recruiting
- Optometry Research Clinic
-
Contact:
- Kai Yip Choi, PhD
- Phone Number: (852)34002934
- Email: kaiyip.choi@polyu.edu.hk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- aged between 4 and 18 years
Exclusion Criteria:
- have received myopia control intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 3000K
Participants will receive a reading lamp of colour temperature 3000K.
|
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.
|
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.
|
Reading lamp with custom-made circuitry to emit light of 6500K colour temperature
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cycloplegic refraction
Time Frame: up to 12 months
|
Refractive error in diopter by autorefractor
|
up to 12 months
|
|
Axial length
Time Frame: up to 12 months
|
Length of the eyeball in millimeter by partial coherence interferometer
|
up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Colour vision
Time Frame: up to 12 months
|
Ability to distinguish colours (pass/fail & severity of defect) measured by pseudoisochromatic plates
|
up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Estimated)
June 30, 2025
Study Completion (Estimated)
June 30, 2027
Study Registration Dates
First Submitted
February 6, 2023
First Submitted That Met QC Criteria
February 14, 2023
First Posted (Actual)
February 17, 2023
Study Record Updates
Last Update Posted (Estimated)
March 1, 2024
Last Update Submitted That Met QC Criteria
February 28, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00000
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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