A Phase 1/2 interventional study of DIMS and The 0.02% ATP Group in Myopia, sponsored by Ruihua Wei. Recruiting at 1 site in China. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by Ruihua Wei · Phase 1/2, Interventional, and Treatment
To evaluate the effectiveness and safety of DIMS, low concentration atropine eye drops,and atropine combined with DIMS in controlling axial length and refraction in children with moderate to high myopia.
In this study, stratified block randomization was employed for random grouping, and the total sample size required as calculated was 410 individuals. Firstly, 410 subjects were assigned ID numbers ranging from 1 to 410. SPSS.26 statistical software was utilized to apply the "random number generator" by setting the "fixed seed number" to "20231121", and subsequently generate random numbers. Once the random numbers were obtained, random sampling and grouping were conducted. This study was a multicenter trial, with block randomization stratified by center. The total sample size of 410 was distributed across 4 cities, and the samples collected in each city were randomly allocated into 5 treatment groups (groups A, B, C, D, and E), with approximately 20 individuals in each group.
Exclusion Criteria:
wear DIMS ,and use placebo,once nightly, both eye
Device: DIMS
wear SP, and use 0.02%ATP eye drops, once nightly, both eye
Drug: The 0.02% ATP Group
wear SP, and use 0.04%ATP eye drops, once nightly, both eye
Drug: The 0.04% ATP Group
wear DIMS, and use 0.02%ATP eye drops, once nightly, both eye
Combination Product: 0.02%ATP+DIMS
wear DIMS, and use 0.04%ATP eye drops, once nightly, both eye
Combination Product: 0.04%ATP+DIMS
wear DIMS ,and use placebo,once nightly, both eye
wear SP, and use 0.02%ATP eye drops, once nightly, both eye
wear SP, and use 0.04%ATP eye drops, once nightly, both eye
wear DIMS, and use 0.02%ATP eye drops, once nightly, both eye
wear DIMS, and use 0.04%ATP eye drops, once nightly, both eye
Best Corrected Visual Acuity
Best Corrected Visual Acuity
Time frame: up to 24 months
Plan to share: No
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Ruihua Wei