NCT06995911

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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

Detailed description

The Virtual Far-sight Reading Device is an innovative ocular protection device integrating advanced far-image optical technology, designed to alleviate asthenopia and prevent myopia progression by simulating a long-distance visual environment. Utilizing a birdbath optical configuration and freeform surface technology, it extends the working distance from 30 cm to over 6 meters, mimicking natural distance viewing to induce ciliary muscle relaxation. The device incorporates a cinematic-grade 2K true-color retinal display combined with a peripheral defocus optical design to generate hyperopic retinal shifts, thereby suppressing myopia development. Additional features include an embedded high-resolution AI camera, full-spectrum LED auxiliary lighting (CCT 5000K, CRI \>90), and compatibility with extensive e-learning resources, making it suitable for diverse scenarios such as online classes, reading, and writing tasks. This study employs a randomized controlled crossover trial to evaluate the efficacy and safety of the device in pre-myopic children and adolescents. Participants are divided into Groups A and B, with Phase I (Days 0-90) requiring Group A to perform daily near-work activities using the device for ≥60 minutes of cumulative daily use, while Group B follows conventional near-work practices without intervention. During Phase II (Days 91-180), the interventions are reversed between groups. Comprehensive ophthalmic evaluations are conducted at baseline, Day 90, and Day 180 to assess changes in spherical equivalent refraction (SER), axial length (AL), myopia incidence rate, binocular visual function parameters, and ocular morphological metrics, ensuring rigorous analysis of both therapeutic outcomes and safety profiles.

Conditions

• Myopia
• Pre-myopia

Interventions

Type	Name	Description
DEVICE	Virtual 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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2025-05-30
• Last updated: 2025-05-30

Locations

1 site across 1 country: China