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

NCT ID: NCT06523504

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 410 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2026-03-31

Brief 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.

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

The DIMS Group

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

Group Type: EXPERIMENTAL

DIMS

Intervention Type: DEVICE

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

0.02% ATP

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

Group Type: EXPERIMENTAL

The 0.02% ATP Group

Intervention Type: DRUG

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

0.04%ATP

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

Group Type: EXPERIMENTAL

The 0.04% ATP Group

Intervention Type: DRUG

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

0.02%ATP+DIMS

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

Group Type: EXPERIMENTAL

0.02%ATP+DIMS

Intervention Type: COMBINATION_PRODUCT

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

0.04%ATP+DIMS

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

Group Type: EXPERIMENTAL

0.04%ATP+DIMS

Intervention Type: COMBINATION_PRODUCT

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

Interventions

DIMS

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

Intervention Type: DEVICE

The 0.02% ATP Group

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

Intervention Type: DRUG

The 0.04% ATP Group

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

Intervention Type: DRUG

0.02%ATP+DIMS

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

Intervention Type: COMBINATION_PRODUCT

0.04%ATP+DIMS

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: collaborator

Ruihua Wei

OTHER

Sponsor Role: lead

Responsible Party

Ruihua Wei

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Meinan He

Role: CONTACT

hmn509@tmu.edu.cn

+8613672135765

Facility Contacts

Meinan He

Role: primary

Other Identifiers

2019yj001J-5

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2019yj001J-5

Identifier Type: -

Identifier Source: org_study_id