An interventional study of High-order Phase Element Array Microstructure Design Lens (H.O.P.E.) and 0.02% Atropine Sulfate Eye Drops in Myopia, sponsored by Ruihua Wei. Not yet recruiting at 1 site in China. Open to participants aged 6 Years to 9 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Ruihua Wei · Not applicable, Interventional, and Treatment
A multicenter, prospective, intervention study on the control of myopia in young children using high-order phase element array microstructure lenses (H.O.P.E.) in combination with low-concentration atropine eye drops (0.02%)
This study focused on 6-9-year-old young children as the research subjects, aiming to investigate 1. The effectiveness of using H.O.P.E. lenses alone and in combination with 0.02% atropine eye drops, in order to provide data support and clinical guidance for the clinical effectiveness and safety of the high-order phase unit (H.O.P.E.) array microstructure lenses in young children with myopia.
Exclusion Criteria:
If a subject meets any of the following exclusion criteria, they will not be included in this study:
Wearing H.O.P.E. lens frame glasses (provided by Shenyang Kangnd Medical Technology Co., Ltd.)
Device: High-order Phase Element Array Microstructure Design Lens (H.O.P.E.)
Use 0.02% atropine sulfate eye drops (provided by Shenyang Xingqi Eye Pharmaceuticals Co., Ltd.)
Drug: 0.02% Atropine Sulfate Eye Drops
Wearing H.O.P.E. lens frame glasses (provided by Shenyang Kangnd Medical Technology Co., Ltd.); Use 0.02% atropine sulfate eye drops (provided by Shenyang Xingqi Eye Pharmaceuticals Co., Ltd.)
Device: High-order Phase Element Array Microstructure Design Lens (H.O.P.E.) · Drug: 0.02% Atropine Sulfate Eye Drops
Wear the H.O.P.E. lens frame glasses and use the placebo. Use it once per night for both eyes.
Wear single-vision frame glasses and use 0.02% atropine sulfate eye drops twice a day, once at night for both eyes.
The final spherical equivalent refractive error (SER) measured by cycloplegic refraction combined with both automated and subjective refraction after 12 months of wearing glasses, compared with the baseline value.
Time frame: From enrollment to the end of treatment at 12 months
The change in AL (axial length) from the baseline after wearing the glasses for 12 months
Time frame: From enrollment to the end of treatment at 12 months
Plan to share: No
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Ruihua Wei