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

NCT06995911 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-05-30

No results posted yet for this study

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

Conditions

  • Myopia
  • Pre-myopia

Interventions

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.

Sponsors & Collaborators

  • Shanghai Eye Disease Prevention and Treatment Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06995911 on ClinicalTrials.gov