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The Evaluation of Safety and Myopia Progression Control Using Novel Spectacle Lens

NCT05886348 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2026-03-23

No results posted yet for this study

Summary

The goal of this clinical trial is to test Novel spectacle lenses in myopic children. The main question it aims to answer are: safety and efficacy of the lenses. Participants will be asked to wear spectacles and participate in eye exams and questionnaires. Researchers will compare Novel spectacle lenses and general single vision spectacle lenses to see if the Novel spectacle lenses correct myopic ametropia, slow the progression of myopia and axial elongation.

Conditions

  • Myopia

Interventions

DEVICE

Model-A Novel spectacle lens

Model-A Novel spectacle lenses will be given to 1 arm to wear for 36 months

DEVICE

Model-B Novel spectacle lens

Model-B Novel spectacle lenses will be given to 1 arm to wear for 36 months

DEVICE

Single vision spectacle lens

Single Vision Spectacle lenses will be given to 1 arm to wear for 36 months

Sponsors & Collaborators

  • HOYA Lens Thailand LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-31
Primary Completion
2026-05-31
Completion
2027-05-31

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 NCT05886348 on ClinicalTrials.gov