BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment (BRIGHT LIGHT)
Benefit of Repeated Illumination in Group of High Myopes and Treatment-resistant Cases (BRIGHT) - Repeated Low-Level Red Light (RLRL) Therapy (Evaluating RLRL Treatment in High Myopes and Non-Responders to Conventional Myopia Control) (BRIGHT-LIGHT)
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.
A tanulmány áttekintése
Állapot
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Rong Qiang Chua, MSc
- Telefonszám: 65767200
- E-mail: chua.rong.qiang@seri.com.sg
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Claudia Lam, MSc
- Telefonszám: 65767200
- E-mail: claudia.lam.x.y@seri.com.sg
Tanulmányi helyek
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Singapore, Szingapúr
- Singapore National Eye Centre
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Singapore, Szingapúr
- Singapore Eye Research Institute
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
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.
Informed consent 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.
Contraindication to repeated low-level red-light therapy.
Inability to attend follow-up visits.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Nem véletlenszerű
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: Repeated Low-Level Red-Light (RLRL) Therapy
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. |
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.
Más nevek:
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Aktív összehasonlító: Conventional Myopia Management
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. |
Children are continued on existing myopia treatment strategy |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Change in Best-Corrected Visual Acuity
Időkeret: Baseline to 12 months, with assessments at 1, 3, 6 and 12 months.
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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. |
Baseline to 12 months, with assessments at 1, 3, 6 and 12 months.
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Occurrence of Retinal Structural Abnormalities
Időkeret: Throughout the 12-month study period.
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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. |
Throughout the 12-month study period.
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Occurrence of Retinal Functional Abnormalities
Időkeret: Throughout the 12-month study period.
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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. |
Throughout the 12-month study period.
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Proportion of Participants Achieving Effective Myopia Control
Időkeret: At 12 months.
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Proportion of participants achieving effective myopia control after 12 months of RLRL therapy, assessed using axial elongation and spherical equivalent refractive progression. |
At 12 months.
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Change in Axial Length
Időkeret: Baseline to 12 months, with measurements at 1, 3, 6 and 12 months.
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Change in axial length, measured in millimetres, from baseline. Longitudinal changes will be evaluated using mixed-model analyses. |
Baseline to 12 months, with measurements at 1, 3, 6 and 12 months.
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Change in Spherical Equivalent Refraction
Időkeret: Baseline to 12 months, with measurements at 6 and 12 months.
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Change in cycloplegic spherical equivalent refraction, measured in dioptres, from baseline. Longitudinal changes will be evaluated using mixed-model analyses. |
Baseline to 12 months, with measurements at 6 and 12 months.
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Change in Choroidal Thickness
Időkeret: Baseline to 12 months, with measurements at 1, 3, 6 and 12 months.
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Change in choroidal thickness, measured using optical coherence tomography, from baseline to assess the anatomical response to treatment. |
Baseline to 12 months, with measurements at 1, 3, 6 and 12 months.
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Change in Retinal Function
Időkeret: - Through 12 months, according to the protocol-specified assessment schedule.
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Changes in retinal function assessed using contrast sensitivity, dark-adapted testing, microperimetry and multifocal electroretinography. |
- Through 12 months, according to the protocol-specified assessment schedule.
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Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Bryan XR Sim, MD FRCOphth, Singapore National Eye Centre (SNEC)/Singapore Eye Research Institute (SERI)
Publikációk és hasznos linkek
Általános kiadványok
- 1. He M, Zeng J, Liu Y, Xu J, Pokharel GP, Ellwein LB. Refractive error and visual impairment in urban children in southern China. Invest Ophthalmol Vis Sci 2004;45(3):793-9. 2. Lin LL, Shih YF, Hsiao CK, Chen CJ. Prevalence of myopia in Taiwanese schoolchildren: 1983 to 2000. Ann Acad Med Singap 2004;33(1):27-33. 3. Wang H, Li Y, Qiu K, et al. Prevalence of myopia and uncorrected myopia among 721,032 schoolchildren in southern China: the Shantou Myopia Study. Br J Ophthalmol 2022. 4. Hashemi H, Rezvan F, Ostadimoghaddam H, Abdollahi M, Hashemi M, Khabazkhoob M. High prevalence of refractive errors in a rural population. Clin Exp Ophthalmol 2013;41(7):635-43. 5. Sun J, Zhou J, Zhao P, et al. High prevalence of myopia in Chinese university students. Invest Ophthalmol Vis Sci 2012;53(12):7504-9. 6. Pan CW, Zheng YF, Anuar AR, et al. Prevalence of refractive errors in a multiethnic Asian population. Invest Ophthalmol Vis Sci 2013;54(4):2590-8. 7. Wang TJ, Chiang TH, Wang TH, Lin LL, Shih YF. Changes of ocular refraction in Taiwan university students. Eye (Lond) 2009;23(5):1168-9. 8. Holden BA, Fricke TR, Wilson DA, et al. Global prevalence of myopia and high myopia (2000-2050). Ophthalmology 2016;123(5):1036-42. 9. GBD Vision Loss Expert Group. Causes of blindness and vision impairment in 2020. Lancet Glob Health 2021;9(2):e144-e160. 10. Fricke TR, Holden BA, Wilson DA, et al. Global cost of correcting vision impairment. Bull World Health Organ 2012;90(10):728-38. 11. Flitcroft DI, He M, Jonas JB, et al. IMI-Defining and classifying myopia. Invest Ophthalmol Vis Sci 2019;60(3):M20-M30. 12. Ikuno Y. Complications of high myopia. Retina 2017;37(12):2347-51. 13. Bullimore MA, Brennan NA. Myopia control: why each diopter matters. Optom Vis Sci 2019;96(6):463-5. 14. Gong Q, Janowski M, Luo M, et al. Atropine in childhood myopia: meta-analysis. JAMA Ophthalmol 2017;135(6):624-30. 15. Sun Y, Xu F, Zhang T, et al. Orthokeratology for myopia control: meta-analysis
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- SingaporeNEC_RLRL
- 2026-0840 (Egyéb azonosító: Singapore Health Services)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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.
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