Refractive ErrorsNCT05733182
Effect of Colour Temperature of Reading Lamp on Refractive Error Development
A study testing 3000K Reading lamp, 4500K Reading lamp and 6500K Reading lamp in people with Refractive Errors, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors
- What is being tested?
- 3000K Reading lamp, 4500K Reading lamp and 6500K Reading lamp
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 798 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- aged between 4 and 18 years
Who cannot join
- have received myopia control intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Optometry Research Clinic
Hong Kong, Kowloon, 000000
Kai Yip Choi, PhD, (852)34002934, kaiyip.choi@polyu.edu.hk
About this study
This is a 12-month longitudinal randomized controlled trial aiming to evaluate the effect of colour temperature of reading lamp on refractive error development.
Read the 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.
- Conditions
- Refractive Errors
- Being tested
- 3000K Reading lamp, 4500K Reading lamp, 6500K Reading lamp
- Keywords
- Myopia, Environment, Colour temperature, Lighting
- Medical subject headings
- Refractive Errors, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3000K Reading lampDevice
Reading lamp with custom-made circuitry to emit light of 3000K colour temperature
4500K Reading lampDevice
Reading lamp with custom-made circuitry to emit light of 4500K colour temperature
6500K Reading lampDevice
Reading lamp with custom-made circuitry to emit light of 6500K colour temperature
| Study group | Role | What they receive |
|---|---|---|
| 3000K | Active comparator | Participants will receive a reading lamp of colour temperature 3000K. Receives: Device: 3000K Reading lamp |
| 4500K | Active comparator | Participants will receive a reading lamp of colour temperature 4500K. Receives: Device: 4500K Reading lamp |
| 6500K | Active comparator | Participants will receive a reading lamp of colour temperature 6500K. Receives: Device: 6500K Reading lamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycloplegic refraction
Refractive error in diopter by autorefractor
Measured: up to 12 months
Axial length
Length of the eyeball in millimeter by partial coherence interferometer
Measured: up to 12 months
Secondary outcomes (1)
Colour vision
Ability to distinguish colours (pass/fail \& severity of defect) measured by pseudoisochromatic plates
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Jul 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 798 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr CHOI Kai Yip, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733182
- Sponsor's protocol ID
- 00000
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Colour Temperature of Reading Lamp on Refractive Error Development
- ClinicalTrials.gov ID
- NCT05733182
- Acronym / sponsor ID
- 00000
- Conditions
- Refractive Errors
- Keywords
- Myopia, Environment, Colour temperature, Lighting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 798 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| 3000K | Active comparator | Device: 3000K Reading lampParticipants will receive a reading lamp of colour temperature 3000K. |
| 4500K | Active comparator | Device: 4500K Reading lampParticipants will receive a reading lamp of colour temperature 4500K. |
| 6500K | Active comparator | Device: 6500K Reading lampParticipants will receive a reading lamp of colour temperature 6500K. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- aged between 4 and 18 years
Key exclusion criteria (1 listed)
- have received myopia control intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3000K Reading lampReading lamp with custom-made circuitry to emit light of 3000K colour temperature | Device | 3000K |
| 4500K Reading lampReading lamp with custom-made circuitry to emit light of 4500K colour temperature | Device | 4500K |
| 6500K Reading lampReading lamp with custom-made circuitry to emit light of 6500K colour temperature | Device | 6500K |
Primary outcome
Cycloplegic refraction
Time frame: up to 12 months
Refractive error in diopter by autorefractor
Axial length
Time frame: up to 12 months
Length of the eyeball in millimeter by partial coherence interferometer
1 secondary outcome
Colour vision
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
Related trials for Refractive Errors
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3000K Reading lamp, 4500K Reading lamp and 6500K Reading lamp in people with Refractive Errors, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Yip Choi, PhD ((852)34002934, kaiyip.choi@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cycloplegic refraction (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.