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

Efficacy and Safety of Low-concentration Atropine Eye Drops (0.02%, 0.04%) Combined With Defocus Incorporated Multiple Segments (DIMS) for Moderate and High Myopia Control

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.

Study Overview

• Status: Recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: DIMS; Drug: The 0.02% ATP Group; Drug: The 0.04% ATP Group; Combination product: 0.02%ATP+DIMS; Combination product: 0.04%ATP+DIMS

Detailed Description

In this study, stratified block randomization was employed for random grouping, and the total sample size required as calculated was 410 individuals. Firstly, 410 subjects were assigned ID numbers ranging from 1 to 410. SPSS.26 statistical software was utilized to apply the "random number generator" by setting the "fixed seed number" to "20231121", and subsequently generate random numbers. Once the random numbers were obtained, random sampling and grouping were conducted. This study was a multicenter trial, with block randomization stratified by center. The total sample size of 410 was distributed across 4 cities, and the samples collected in each city were randomly allocated into 5 treatment groups (groups A, B, C, D, and E), with approximately 20 individuals in each group.

• Study Type: Interventional
• Enrollment (Estimated): 410
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Meinan He; Phone Number: +8613672135765; Email: hmn509@tmu.edu.cn

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 120120
      • Recruiting
      • Tianjin Medical University Eye Hospital
      • Contact: Meinan He

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• School-age children aged 6 to 12 years (including boundary value)
• Children with moderate or high myopia (subjective refraction after cycloplegia: -9.00D≤spherical equivalent (SE)≤-3.00D, with-rule astigmatism (C)≤2.00D, against-rule astigmatism (C)≤1.00D, anisometropia of both eyes≤2.50D)
• Binocular best corrected visual acuity (BCVA)≥0.8 (five-point visual acuity 4.9)
• Agree with the study scheme and sign the informed consent
• Note: if both eyes meet the inclusion criteria, the eye with higher spherical equivalent is the study eye; if one eye meets the inclusion criteria, the eye is the study eye.

Exclusion Criteria:

• Used or currently using orthokeratology, multifocal contact lenses, defocusing framework lenses, atropine eye drops and other myopia control means in the past month; used red light treatment in the past
• Children with obvious strabismus and amblyopia
• With congenital eye disease, such as congenital cataract, congenital retinal disease
• Secondary myopia (such as premature retinopathy or other eye diseases in infants and children caused secondary myopia), or myopia combined with systemic syndrome (such as Marfan syndrome)
• Had internal eye surgery (such as cataract extraction, intraocular lens implantation, anti-glaucoma surgery, etc.)
• Refractive medium opacity (such as corneal disease, crystal opacity, etc.)
• Bnormal intraocular pressure and clinical significance (IOP <10 mmHg or IOP >21mmHg or binocular IOP difference ≥5mmHg)
• Fundus chorioretinopathy (except for high myopia fundus degenerative changes) or other intraocular diseases
• Optic nerve damage or congenital optic nerve dysfunction
• Can not be regularly checked
• The adjustment range is less than 8D or obvious near difficulties
• Other reasons researchers think it is not suitable for inclusion in researchers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The DIMS Group; wear DIMS ,and use placebo,once nightly, both eye	Device: DIMS; wear DIMS ,and use placebo,once nightly, both eye
Experimental: 0.02% ATP; wear SP, and use 0.02%ATP eye drops, once nightly, both eye	Drug: The 0.02% ATP Group; wear SP, and use 0.02%ATP eye drops, once nightly, both eye
Experimental: 0.04%ATP; wear SP, and use 0.04%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
Experimental: 0.02%ATP+DIMS; wear DIMS, and use 0.02%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
Experimental: 0.04%ATP+DIMS; wear DIMS, and use 0.04%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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Corrected Visual Acuity	Best Corrected Visual Acuity	up to 24 months

Collaborators and Investigators

• Sponsor: Ruihua Wei
• Collaborators: Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: August 30, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 2019yj001J-5 (Other Grant/Funding Number: Beijing Bethune Charitable Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No