An interventional study of red light and distant image screen and red light in Myopia, sponsored by Beijing Tongren Hospital. Completed at 1 site in China. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by Beijing Tongren Hospital · Not applicable, Interventional, and Treatment
This study aims to assess the efficacy and safety of daily exposure to 650-nm low-level red light (RL) and distant-image therapy (DIT) for myopia treatment.
This was a randomized clinical trial. Children aged 8 to 10 years with a spherical equivalent error (SER) ranging from -1 to -1.5 diopters (D) were enrolled, and were randomly allocated to the following treatment group: RL, DIT, RL plus DIT, and control in a 1:1:1:1 ratio. The primary outcomes were one-year change in SER and axial length.
1,007 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 120 is above the median of 80 across 803 interventional studies indexed under Myopia.
Browse Myopia studies →Beijing Tongren Hospital is the lead sponsor of 163 studies on the registry; 53 are open to participants now.
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1. Age between 8 and 10 years old. 2. The spherical equivalent error after pupil dilation was between -1.0 D and -1.5D.
3. Corneal astigmatism ≤ 1.25D. 4. Interocular refraction discrepancy ≤ 1.5D. 5. Near-distance exophoria \< 10 prism diopters (△) and far-distance exophoria \< 6 prism diopters (△).
6. Willingness to participate in the study and signed informed consent.
Exclusion Criteria:
1. Intraocular pressure was below 10 mmHg or higher than 22 mm Hg. 2. Presence of amblyopia, or ocular pathological conditions such as retinal, lens, or corneal disorders.
3. Children currently using atropine or orthokeratology for myopia control. 4. Patients with systemic and immune disorders such as albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, diabetes, etc.
5. Individuals with conditions like Tourette's syndrome or epilepsy.
Children in this group received a red-light apparatus (LS-03B; Yishiliang Inc), which has been deemed safe by the State Administration for Market Regulation of China. They were directed to utilize this apparatus twice a day for 3-minute sessions, ensuring a gap of over 4 hours between each use.
Device: red light
participants were given a distant-image screen ( RIO-Max2.0; Ruishi Inc), and were asked to use this device for ≥1 hour/day
Device: distant image screen
For this group, participants were given a red-light device (LS-03B; Yishiliang Inc) and a distance image screen device ( RIO-Max2.0; Ruishi Inc), and were asked to use red-light twice a day for 3-minute sessions, ensuring a gap of over 4 hours between each use, and use distant image screen for ≥1 hour/day
Device: red light and distant image screen
No intervention
red light plus distant image screen, children use these two devices at the same time
children use red light for 3 minutes each time, twice a day
Children in this group were asked to use this device for ≥1 hour/day
Changes in axial length
Axial length was measured using an optical biometer (Colombo IOL, Moptim)
Time frame: one year
Changes in spherical equivalent error
Spherical equivalent error was calculated from the dioptric powers of the sphere and half of the cylinder.The children's pupils were dilated using tropicamide eyedrops, then SER was subsequently measured using an auto refractor (ARK-510A, Nidek Co Ltd)
Time frame: one year
Plan to share: No
Ran from Apr 2023 to primary completion in May 2023, 1 month.
Of 195 non-industry interventional studies with no phase under Myopia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's 1 month is below that.
Counting every sponsor, half of 379 studies reached it within 19 months; a quarter within 5 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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