RecruitingNot ApplicableNCT06995911

Virtual Far-sight Reading Device for Myopia Intervention Among Pre-myopic Children

A Randomized Controlled Clinical Trial on the Efficacy and Safety of the Virtual Far-sight Reading Device for Myopia Intervention in Pre-myopic Children

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Enrollment

80 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Myopia Pre-myopia

Summary

This clinical trial wants to find out if the Virtual Far-sight Reading Device can help prevent or slow down myopia progression in children and teenagers with pre-myopia. We also want to know what makes this treatment work better for some participants and check for any eye or body-related side effects over time. Main questions: Can using the Virtual Far-sight Reading Device reduce the risk of myopia? Is the device safe to use every day for up to 6 months? What we'll do: Researchers will compare two groups of children: Group A: Uses the device for reading/writing (at least 1 hour daily) Group B: Does regular reading/writing without the device After 90 days, the groups will switch to see if the results stay the same. Participants will: * Have free eye checkups 3 times over 6 months * Use the device during homework time (if in the desk group) * Report any eye discomfort or problems

Eligibility

Min Age: 6 YearsMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Virtual Far-sight Reading Device for people with myopia and pre-myopia. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVirtual Far-sight Reading Device

The Virtual Far-sight Reading Device utilizes a birdbath optical configuration and freeform surface technology to extend the working distance from 30 cm to over 6 meters, thereby simulating distance viewing conditions and maintaining ciliary muscle relaxation. Study participants were required to engage in reading and writing tasks using the device for a cumulative daily duration of at least 1 hour.