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Myopia Prevention in Young Premyopic Children Using Defocus Incorporated Multiple Segments Spectacle Lenses

NCT07765550 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-08-14

No results posted yet for this study

Summary

Pre-myopia refers to a condition in which children have not yet developed myopia but exhibit insufficient hyperopic reserve (≤ +0.75 D). This is particularly relevant for young children aged 6 years and under; if their hyperopic reserve is depleted prematurely and they progress into the pre-myopia stage, the likelihood of developing myopia or even high myopia in the future becomes extremely high. Therefore, this study plans to conduct a parallel-design, open-label, single-center randomized controlled clinical trial to evaluate the efficacy and safety of artificial intelligence-assisted Defocus Incorporated Multiple Segments Triple Enhanced Design (AI-DIMS) spectacle lenses in preventing and controlling myopia in pre-myopic children aged 3 to 6 years.

Conditions

  • Pre-myopia
  • Myopia

Interventions

DEVICE

Artificial Intelligence-Assisted Defocus Incorporated Multiple Segment Triple Enhanced Design (AI-DIMS TED) Spectacle Lenses

The AI-DIMS TED defocus spectacle frame, featuring DIMS TED lenses and an intelligent AI frame, is designed to be worn for at least 10 hours per day. The frame automatically tracks and records wearing duration parameters.

DEVICE

Smartwatches

Inserted prompt system of the smartwatches can remind the users to go outside. Inserted sensors can record outdoor parameters such as outdoor time, light intensity, activity pattern, etc.

Sponsors & Collaborators

  • HOYA Lens Thailand Limited

    collaborator UNKNOWN

  • Shanghai Eye Disease Prevention and Treatment Center

    lead OTHER

Principal Investigators

  • He, Prof · Shanghai Eye Disease Prevention and Treatment Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-09-12
Primary Completion
2028-05-31
Completion
2028-08-31

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 NCT07765550 on ClinicalTrials.gov