Table 2.
Effectiveness and Safety Outcomes
| Reported Data on Clinical Effectiveness Outcomes (Intervention Group Vs Control Group) | ||||||
|---|---|---|---|---|---|---|
| Type of Intervention | Author, Year; Study Design; Sample Size | Change in Axial Length, mm | Change in Spherical Equivalent Refraction, D | Change in Choroidal Thickness, µm | Myopia Incidence | Reported Data of Clinical Safety Outcomes |
| Red light | He et al., 202323; RCT; N = 278 | Intervention = +0.30 ± 0.27Control = +0.47 ± 0.25Absolute mean difference = +0.17(95% CI = 0.11–0.23)P < 0.001 | Intervention = −0.35 ± 0.54Control = −0.76 ± 0.60Absolute mean difference = −0.41 (95% CI = −0.56 to –0.26)P < 0.001 | Intervention = +3.0 ± 16.9Control = −9.2 ± 22.3P < 0.001 | Intervention = 40.8%Control = 61.3%Absolute mean difference = 20.4% (95% CI = 7.9%–33.1%)P = 0.003Relative risk = 0.67 (95% CI = 0.51–0.86) | No functional damage or adverse effects reported |
| Red light | Chen et al., 202322; RCT; N = 102 | First 12 moIntervention = +0.01 (95% CI = −0.05 to 0.07)Control = +0.39 (95% CI = 0.33 to 0.45)P < 0.053 mo reboundIntervention (compared with dataat the time of treatmentcessation) = +0.16 (95% CI = 0.11 to 0.22)P < 0.05 | First 12 moIntervention = +0.05 (95% CI = −0.08 to 0.19)Control = −0.64(95% CI = −0.78 to −0.51)P < 0.053 mo reboundIntervention (compared with dataat the time of treatmentcessation) = −0.20(95% CI = −0.26 to −0.14)P < 0.05 | Intervention = +21.57 (95% CI = 12.00 to 31.13)Control = −11.30 (95% CI = −17.37 to −5.23)P < 0.05 | Not available | No functional damage or adverse effects reported |
| Red light | Dong et al., 202324; RCT; N = 112 | Intervention = +0.02 ± 0.11Control = +0.13 ± 0.10P < 0.001 | Intervention = +0.06 ± 0.30Control = −0.11 ± 0.33P = 0.003 | Not available | Not available | No functional damage or adverse effects reported relating to RLRL therapy |
| Red light | Jiang et al., 202225; RCT; N = 264 | Intervention = +0.13 (95% C = 0.09 to 0.17)Control = +0.38 (95% CI = 0.34 to 0.42)Mean difference = +0.26 (95% CI = 0.20 to 0.31)P < 0.001 | Intervention = −0.20(95% CI = −0.29 to −0.11)Control = −0.79(95% CI = −0.88 to −0.69)Difference = −0.59(95% CI = −0.72 to −0.46)P < 0.001 | Intervention = +12.1 (95% CI = 6.1 to 18.1)Control = −9.5 (95% CI = −15.6 to −3.5)No P value given | Not available | No functional damage or adverse effects reported |
| Red light | Liu et al., 202426; RCT; N = 94 | Intervention = +0.09 ± 0.21Control = +0.28 ± 0.12Difference = 0.19P < 0.001 | Intervention = −0.11 ± 0.44Control = −0.42 ± 0.36Difference = −0.31P < 0.001 | Intervention = +11.99 ± 32.66Control = −28.74 ± 26.89P < 0.001 | Intervention = 20.9%Control = 38.1%Absolute mean difference = 17.2%No P value given | Two children reported intolerance to bright light and dry eye symptoms which were transient and resolved either spontaneously or with minimal intervention |
| Red light | Lin et al., 202327; RCT; N = 210 | Intervention (mild to moderatemyopia) = −0.03 ± 0.11Intervention (severemyopia) = −0.07 ± 0.11Control = −0.08 ± 0.40P < 0.001 | Intervention (mild to moderatemyopia) = +0.06 ± 0.37Intervention (severemyopia) = +0.06 ± 0.30Control = −0.26 ± 1.91P = 0.456 | Not available | Not available | Main adverse reaction to the red light delivery instrument was an afterimage which was alleviated by a short period of eye-closing and rest |
| Red light | Yang et al., 202228; RCT; N = 25 | Not available | Not available | Intervention = −3.44 ± 2.08Control = −2.08 ± 2.08P = 0.635 | Not available | Did not assess adverse effects related to red light therapy |
| Red light | Wang et al., 202329; non-randomized controlled trial; N = 49 | Intervention = −0.08(95% CI = −0.11 to −0.06)Control = +0.08 (95% CI = 0.05 to 0.11)Difference = +0.17 (95% CI = 0.13 to 0.20)P < 0.001 | Interventional = +0.23(95% CI = 0.13 to 0.33)Control = −0.07(95% CI = −0.16 to −0.03)Difference = +0.30(95% CI = −0.42 to −0.18)P < 0.001 | Intervention = +24.21 (95% CI = 14.86 to 33.56)Control = −4.28(95% CI = −15.91 to −7.35)Difference = −27.84 (95% CI = −40.02 to −15.67)P < 0.001 | Not available | No functional damage or adverse effects reported |
| Red light | Xiong et al., 202230; post-trial follow up RWS of Jiang et al., 2022; N = 138 | Baseline to 24 moSVS-SVS = +0.64 ± 0.24SVS-RLRL = +0.44 ± 0.37RLRL-SVS = +0.50 ± 0.28RLRL-RLRL = +0.16 ± 0.37P values between groupsSVS-SVS versus SVS-RLRL: P = 0.366SVS-SVS versus RLRL-SVS: P = 0.156SVS-SVS versus RLRL-RLRL: P < 0.001SVS-RLRL versus RLRL-SVS: P = 1.000SVS-RLRL versus RLRL-RLRL: P = 0.206RLRL-SVS versus RLRL-RLRL: P = 0.005Overall: P < 0.001 | Baseline to 24 moSVS-SVS = −1.24 ± 0.63SVS-RLRL = −0.96 ± 0.70RLRL-SVS = −1.07 ± 0.69RLRL-RLRL = −0.31 ± 0.79P values between groupsSVS-SVS versus SVS-RLRL: P = 1.000SVS-SVS versus RLRL-SVS: P = 1.000SVS-SVS versus RLRL-RLRL: P = 0.001SVS-RLRL versus RLRL-SVS: P = 1.000SVS-RLRL versus RLRL-RLRL: P = 0.325RLRL-SVS versus RLRL-RLRL: P = 0.010Overall: P = 0.003 | Baseline to 24 moSVS-SVS = −16.09 ± 19.37SVS-RLRL = −2.93 ± 25.64RLRL-SVS = −8.66 ± 24.68RLRL-RLRL = +21.49 ± 36.21P values between groupsSVS-SVS versus SVS-RLRL: P = 1.000SVS-SVS versus RLRL-SVS: P = 1.000SVS-SVS versus RLRL-RLRL: P = 0.002SVS-RLRL versus RLRL-SVS: P = 1.000SVS-RLRL versus RLRL-RLRL: P = 0.292RLRL-SVS versus RLRL-RLRL: P = 0.012Overall: P = 0.004 | Not available | No functional damage or adverse effects reported |
| Red light | Zhou et al., 202431; RCT; N = 200 | 0.37-mW group = +0.04 (95% CI = −0.01 to 0.08)0.60-mW group = 0.00(95% CI = −0.05 to 0.05)1.20-mW group −0.04(95% CI = −0.08 to 0.01)Control = +0.27(95% CI = 0.22 to 0.33)Adjusted P < 0.001 for all;adjusted P > 0.05 between all comparisonsof different powers | 0.37-mW group = +0.01(95% CI = −0.12 to 0.15)0.60-mW group = −0.05(95% CI = −0.18 to 0.07)1.20-mW group = +0.16(95% CI = 0.03 to 0.30)Control group = −0.22(95% CI = −0.50 to 0.30)Adjusted P < 0.001 for all;adjusted P > 0.05 between all comparisonsof different powers | 0.37-mW group = +22.63 (95% CI = 12.13 to 33.34)0.60-mW group = +36.17 (95% CI = 24.37 to 48.25)1.20-mW group = +42.59 (95% CI = 23.43 to 66.24)Control group = −5.07 (95% CI = −10.32 to −0.13)Adjusted P < 0.001 for all;adjusted P > 0.05 between all comparisonsof different powers | Not available | No functional damage or adverse effects reported |
| Red light | Zhao et al., 202332; non-randomized controlled trial; N = 67 | Not available | Not available | Intervention = +14.5 (95% CI = 9.6 to 19.5)Control = −1.7 (95% CI = −9.1 to 5.7)Mean difference = −16.2 (95% CI = 7.8 to 24.7)P < 0.0001 | Not available | Did not assess adverse effects related to red light therapy |
| Red light | Xiong et al., 202133; RCT; N = 200 | Intervention = +25.00 ± 1.11Control = +25.30 ± 0.86P < 0.001 | Intervention = −3.17 ± 2.14Control = −3.82 ± 1.37P < 0.001 | Intervention = +323.91 ± 65.63Control = +269.97 ± 64.11P < 0.001 | Not available | Did not assess adverse effects related to red light therapy |
| Red light | Tian et al., 202234; RCT; N = 224 | Intervention = 0.06(IQR = −0.15 to 0)Control = 0.14(IQR = 0.07 to 0.22)P < 0.001 | Intervention = 0.125(IQR = 0 to 0.375)Control = 0.25(IQR = −0.5 to 0)P < 0.001 | Intervention = +15(IQR = −3 to 34.5)Control = −7(IQR = −28 to 14.5)P < 0.001 | Not available | No functional damage or adverse effects reported |
| Violet light | Mori et al., 202135; RCT; N = 113 | No limited conditions Intervention = +0.728(95% CI = 0.682−0.775)Control = +0.758(95% CI = 0.711−0.810)Mean difference = −0.03 (95% CI = −0.10 to 0.04)P = 0.381Limited analysis to “children who firststarted using eyeglasses” and “nearwork time of less than 180 min”Intervention = +0.75(95% CI = 0.65 to 0.86)Control = +0.96 (95% CI = 0.86 to 1.06)Mean difference = −0.21 (95% CI = −0.35 to −0.06)P = 0.006 | No limited conditionsIntervention = −1.421(95% CI = −1.617 to −1.225)Control = −1.531(95% CI = −1.729 to −1.330)Mean difference = +0.11(95% CI = −0.17 to 0.39)P = 0.434Limited analysis to “children who firststarted using eyeglasses” and “nearwork time of less than 180 min”Intervention = −1.54 (95% CI = −1.76 to −1.32)Control = −1.84 (95% CI = −2.06 to −1.63)Mean difference = +0.30 (95% CI = −0.01 to 0.61)P = 0.055 | Not available | Not available | No functional damage or adverse effects reported |
| Violet light | Torii et al., 202236; RCT; N = 43 | Mean change after subgroup analysisof children aged 8−10 yIntervention = 0.14 ± 0.03Control = 0.23 ± 0.02P = 0.016 | Mean change after subgroup analysisof children aged 8–10 yIntervention = −0.12 ± 0.12Control = −0.60 ± 0.10P = 0.008 | Not available | Not available | No functional damage or adverse effects reported |
| Improved classroom lighting | Hua et al., 201537; RCT; N = 317 | Non-myopic childrenIntervention = +0.13 ± 0.17Control = +0.18 ± 0.12P < 0.05Myopic childrenIntervention = +0.20 ± 0.11Control = +0.27 ± 0.10P < 0.01 | Non-myopic childrenIntervention = −0.25 ± 0.40Control = −0.47 ± 0.40P < 0.01Myopic childrenIntervention = −0.25 ± 0.47Control = −0.31 ± 0.46P > 0.05 | Not available | Intervention = 4%Control = 10%P = 0.029 | Did not assess adverse effects related to red light therapy |
| Outdoor light exposure | He et al., 202219; RCT; N = 6295 | Additional 40 min of outdoor time = +0.55 (95% CI = 0.51–0.60)Additional 80 min of outdoor time = +0.57 (95% CI = 0.52−0.62)Control = +0.65(95% CI = 0.60−0.70)P < 0.044 among the three groups | Additional 40 min of outdoor time = −0.84(95% CI = −0.96 to −0.70)Additional 80 min of outdoor time = −0.91(95% CI = −1.03 to −0.79)Control = −1.04(95% CI = −0.91 to −1.17)P > 0.05 among the three groups | Not available | Additional 40 min of outdoor time Incidence risk ratio = 0.84(95% CI = 0.72 to 0.99)P = 0.035Additional 80 min of outdoor time Incidence risk ratio = 0.89(95% CI = 0.79 to 0.99)P = 0.041 | Did not assess adverse effects related to red light therapy |
| Outdoor light exposure | Wu et al., 201820; RCT; N = 930 | Non-myopic childrenIntervention = +0.26 ± 0.18Control = +0.30 ± 0.32Estimated difference = −0.03 (95% CI = −0.06 to −0.01)P = 0.02Myopic childrenIntervention = +0.45 ± 0.28Control = +0.60 ± 0.19Estimated difference = −0.15 (95% CI = −0.28 to −0.02)P = 0.02 | Non-myopic childrenIntervention = −0.32 ± 0.58Control = −0.43 ± 0.75Estimated difference = +0.11 (95% CI = 0.02−0.20)P = 0.02Myopic childrenIntervention = −0.57 ± 0.40Control = −0.79 ± 0.38Estimated difference = +0.23 (95% CI = 0.06−0.39)P = 0.007 | Not available | Odds ratio = 0.65 (95% CI = 0.42−1.01)P = 0.05 | Did not assess adverse effects related to red light therapy |
| Outdoor light exposure | Wu et al., 201321; non-randomized controlled trial; N = 571 | Not available | Non-myopic childrenIntervention = −0.26 ± 0.61Control = −0.44 ± 0.64P = 0.020Myopic childrenIntervention = −0.20 ± 0.69Control = −0.37 ± 0.67P = 0.125 | Not available | Intervention = 8.41%Control = 17.65%P < 0.001 | Not available |
RCT, randomized controlled trial; RLRL, repeated low-level red-light therapy; RWS, real-world survey; SVS, single-vision spectacle.