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Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control

NCT06523504 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2025-09-08

No results posted yet for this study

Summary

To evaluate the effectiveness and safety of DIMS, low concentration atropine eye drops,and atropine combined with DIMS in controlling axial length and refraction in children with moderate to high myopia.

Conditions

  • Myopia

Interventions

DEVICE

DIMS

wear DIMS ,and use placebo,once nightly, both eye

DRUG

The 0.02% ATP Group

wear SP, and use 0.02%ATP eye drops, once nightly, both eye

DRUG

The 0.04% ATP Group

wear SP, and use 0.04%ATP eye drops, once nightly, both eye

COMBINATION_PRODUCT

0.02%ATP+DIMS

wear DIMS, and use 0.02%ATP eye drops, once nightly, both eye

COMBINATION_PRODUCT

0.04%ATP+DIMS

wear DIMS, and use 0.04%ATP eye drops, once nightly, both eye

Sponsors & Collaborators

  • Beijing Tongren Hospital

    collaborator OTHER

  • Ruihua Wei

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2026-03-31
Completion
2026-03-31

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 NCT06523504 on ClinicalTrials.gov