An interventional study of Repeated low-level red-light (RLRL) therapy and Continued existing myopia treatment strategy in Myopia, Myopia Progressing and Myopia Progression, sponsored by Singapore National Eye Centre. Not yet recruiting at 2 sites in Singapore. Open to participants aged 8 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Singapore National Eye Centre · Not applicable, Interventional, and Treatment
Some children's short-sightedness (myopia) continues to worsen despite treatments such as atropine eye drops, myopia-control spectacles or contact lenses. These children may be at greater risk of developing severe short-sightedness and related eye problems later in life.
The BRIGHT-LIGHT study will assess the safety of repeated low-level red-light therapy and explore whether it can slow worsening short-sightedness in children whose myopia is inadequately controlled by conventional treatment. This therapy uses a device that delivers low-power red light to the eyes during short treatment sessions.
Forty children aged 8-16 years will be followed for 12 months: 30 receiving red-light therapy and 10 continuing conventional myopia treatment. Group assignment will depend on the willingness of children and their parents or guardians to start red-light therapy, rather than random allocation.
The main focus is safety, assessed through vision tests, detailed eye scans and tests of retinal function. The study will also assess changes in eye length and spectacle prescription to explore the treatment's effect on myopia progression.
Childhood myopia progression is largely associated with elongation of the eye. Although existing treatments can slow progression, some children continue to worsen despite treatment. Evidence on repeated low-level red-light (RLRL) therapy in children with an inadequate response to conventional myopia control remains limited.
BRIGHT-LIGHT is a prospective, non-randomised, open-label interventional cohort study with a concurrent control group. It is designed primarily to characterise safety and provide exploratory evidence of treatment response in this clinically important subgroup. A planned 3:1 allocation provides greater exposure to the intervention for safety assessment while retaining a comparator cohort receiving conventional care.
Participants who accept RLRL therapy will enter the intervention group. Those who decline RLRL therapy but agree to study follow-up will enter the control group and continue conventional myopia management. Participants using myopia-control spectacles or multifocal contact lenses may either continue these treatments alongside RLRL therapy or discontinue them when switching to RLRL therapy. Participants receiving atropine must discontinue atropine before starting RLRL therapy.
The study places particular emphasis on detecting possible retinal effects. Serial assessments will examine both retinal structure and function, alongside visual acuity and treatment-related symptoms. Retinal imaging and functional testing are intended to identify changes that may not be apparent from routine vision testing alone. Protocol-defined withdrawal criteria include a decrease in best-corrected visual acuity, retinal structural abnormalities or a serious adverse event. Participants who withdraw will undergo a safety evaluation.
Safety findings will be summarised descriptively. Longitudinal mixed-model analyses will evaluate changes in axial length and spherical equivalent refraction. Changes in choroidal thickness and retinal function will provide additional information about treatment response. The sample size is based on recruitment feasibility within the specialised clinical population, and the findings are intended to support exploratory and hypothesis-generating analyses.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 40 is below the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Singapore National Eye Centre is the lead sponsor of 87 studies on the registry; 14 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Aged 8-16 years at enrolment.
Cycloplegic spherical equivalent refraction between -3.00 and -20.00 dioptres.
Astigmatism ≤6.00 dioptres.
Documented poor response to conventional myopia-control treatment, defined as axial elongation ≥0.30 mm/year or myopia progression ≥0.50 dioptres/year in at least one eye despite treatment.
Best-corrected visual acuity of 6/9 or better in both eyes.
obtained from a parent or guardian.
Exclusion Criteria:
Orthokeratology lens use.
Not currently receiving any myopia-control treatment.
Ocular disease other than refractive error.
Strabismus or a binocular vision disorder.
Systemic disease affecting study participation.
to repeated low-level red-light therapy.
Inability to attend follow-up visits.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive repeated low-level red-light (RLRL) therapy using the Eyerising Myopia Management Device for 12 months. Each session lasts 3 minutes, with two sessions per treatment day separated by at least 4 hours, up to 10 sessions per week. Participants using myopia-control spectacles or multifocal contact lenses may continue these treatments alongside RLRL or discontinue them and switch to RLRL alone. Participants receiving atropine eye drops must discontinue atropine before starting RLRL.
Device: Repeated low-level red-light (RLRL) therapy
Participants will continue conventional myopia-control treatment, such as atropine eye drops, myopia-control spectacles or multifocal contact lenses, without RLRL therapy. This concurrent control group will undergo study assessments over 12 months to allow comparison of safety findings and myopia progression with the RLRL group.
Other: Continued existing myopia treatment strategy
Repeated low-level red-light (RLRL) therapy will be administered using the Eyerising Myopia Management Device, which delivers red light at a wavelength of 650 ± 10 nm and an output power of 2.0 ± 0.5 mW. Treatment consists of 3-minute sessions, twice per treatment day, separated by at least 4 hours, with a maximum of 10 sessions per week over 12 months. Participants may continue existing myopia-control spectacles or multifocal contact lenses alongside RLRL or switch to RLRL alone. Atropine eye drops must be discontinued before starting RLRL.
Also known as: red light
Children are continued on existing myopia treatment strategy
Change in Best-Corrected Visual Acuity
Change in best-corrected distance and near visual acuity, measured in logMAR units, to assess visual safety during treatment. A decrease of at least one line in best-corrected visual acuity meets the protocol-defined withdrawal criterion.
Time frame: Baseline to 12 months, with assessments at 1, 3, 6 and 12 months.
Occurrence of Retinal Structural Abnormalities
Number and proportion of participants developing retinal structural abnormalities during follow-up. Retinal safety assessments include optical coherence tomography of the macula, fundus photography, fundus autofluorescence and optical coherence tomography angiography.
Time frame: Throughout the 12-month study period.
Occurrence of Retinal Functional Abnormalities
Number and proportion of participants developing retinal functional abnormalities during follow-up. Assessments include colour vision, Amsler grid testing, contrast sensitivity, dark-adapted testing, microperimetry and multifocal electroretinography to detect potential retinal toxicity.
Time frame: Throughout the 12-month study period.
Proportion of Participants Achieving Effective Myopia Control
Proportion of participants achieving effective myopia control after 12 months of RLRL therapy, assessed using axial elongation and spherical equivalent refractive progression.
Time frame: At 12 months.
Change in Axial Length
Change in axial length, measured in millimetres, from baseline. Longitudinal changes will be evaluated using mixed-model analyses.
Time frame: Baseline to 12 months, with measurements at 1, 3, 6 and 12 months.
Change in Spherical Equivalent Refraction
Change in cycloplegic spherical equivalent refraction, measured in dioptres, from baseline. Longitudinal changes will be evaluated using mixed-model analyses.
Time frame: Baseline to 12 months, with measurements at 6 and 12 months.
Change in Choroidal Thickness
Change in choroidal thickness, measured using optical coherence tomography, from baseline to assess the anatomical response to treatment.
Time frame: Baseline to 12 months, with measurements at 1, 3, 6 and 12 months.
Change in Retinal Function
Changes in retinal function assessed using contrast sensitivity, dark-adapted testing, microperimetry and multifocal electroretinography.
Time frame: - Through 12 months, according to the protocol-specified assessment schedule.
Plan to share: No — There are currently no plans to share individual participant data with other researchers. Study findings will be disseminated through peer-reviewed publications in aggregate form, without identifying individual participants.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Singapore National Eye Centre