Effect of Repeated low-level red light therapy in.pptx

effect b of repeated low level red light therapy for control of myopia in children ,a multicentric study

1. Effect of Repeated low-level red light therapy in myopia control in children A Multicentre Randomised Controlled trial Dr Aswathi Venugopal

2. Article citation Jiang Y, Zhu Z, Tan X, Kong X, Zhong H, Zhang j, Xiong R , Yuan Y Ophthalmology.2021 Dec 1:S0161-6420(21)00916-7

3. Aim of study Assess the efficacy and safety of repeated low level red light (RLRL) therapy in myopia control in children.

4. Methodology Study Design : Multicentre , randomised, parallel group, single-blind clinical trial Study duration : 1 year Study setting : 5 study centres from 4 tertiary hospitals in China Study population : A total of 264 eligible children – July to August 2019, follow up completed in August 2020

5. Study Design RCT RLRL + SVS SVS Intervention group Control group

6. Eligibility criteria Inclusion criteria Children aged 8-13 years with Myopia of cycloplegic SER of -1 to -5.00D Astigmatism ≤ 2.50 D Anisometropia ≤ 1.50D BCVA of ≥ o.o logMAR in either eye Exclusion criteria - Strabismus, binocular vision abnormalities, other ocular abnormalities or systemic disease - children who have had previous myopia control treatement .

7. Randomisation and masking Eligible children were randomly allocated to either the intervention arm (RLRL treatment + single vision spectacle (svs) or control arm ( SVS correction) based on a centralised web-based randomization service system. Single blinded trial- outcome assessors were masked to the treatment allocation

8. Intervention All children wore SVS throughout the study and updated their spectacle if needed Children in the intervention group additionally received RLRL therapy – a desktop light therapy device delivering low-level red light of 650nm at an illuminance of 1600lux and a power of 0.29mW through a 4mm pupil, a level considered safe for direct ocular exposure. Children in the RLR group completed treatment , under the supervision of their parents – 3 minutes per session, 2 sessions per day with a minimum interval of 4 hours, 5 days per week- repeated daily until the last follow up visit at 12 months

9. Intervention compliance monitoring The device connected to internet with an automated diary function to record the date and time of treatment sessions, as well as to control light emission as per the predefined treatment schedule.

10. Main Outcome Measures Measured at baseline and compared to the 1-, 3- , 6- and 12 month follow up visits. Primary outcomes : Changes in AL Secondary outcomes: - Changes in cycloplegic SER ( myopic progression) - Other parameters : ACD, CC, WTW corneal diameter and VA - Choroidal thickness – an optional outcome.

11. Results A total of 264 myopic children were included in the study , with 119 children randomly assigned to the RLRL group, and 145 to the SVS group by simple random sampling.

12. Trial profile A total of 117 children in the RLRL and 129 children in the SVS group were included in the analysis.

13. Primary Outcome 12- month adjusted mean axial elongation- 0.13mm in RLRL group & 0.38 mm in the SVS group

14. Secondary outcome Adjusted mean SER progression over 12 months was -0.29 D ( RLRL group) & -0.79 D (SVS group).

15. RLRL similar to SVS for mean changes in other ocular biometric parameters ( ACD, CC, & WTW ) At the 12 –month follow up visit , the proportion of children whose UCVA improved by at least 2 lines was significantly greater the RLRL GROUP than those in SVS Group ( 21.8% versus 7.9% ; p< 0.001) The association between compliance and myopia progression was significant. No severe adverse events were reported.

16. Limitation of study Lack of masking with a light treatment simulator as a placebo. 50% of children were lost to follow up at 6 months, although tried to maximise follow up at 12 month visit. Observed treatment efficacy generalizable only to the device used in the study Short duration of study to observe full myopia control effects Unable to describe possible stop and rebound effects or efficacy in other ethnic groups.

17. Conclusion Among Chinese children aged 8-13 years with myopia , RLRL therapy is safe and effective new alternative treatment for myopia control with good user acceptability and no documented functional and structural balance.