Actively Recruiting

Phase 1
Phase 2
Age: 6Years - 12Years
All Genders
NCT06523504

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

Led by Ruihua Wei · Updated on 2025-09-08

410

Participants Needed

1

Research Sites

112 weeks

Total Duration

On this page

Sponsors

R

Ruihua Wei

Lead Sponsor

B

Beijing Tongren Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 6Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • School-age children aged 6 to 12 years (including boundary value)
  • Children with moderate or high myopia with spherical equivalent between -9.00D and -3.00D
  • With-rule astigmatism C= 2.00D, against-rule astigmatism CC= 1.00D
  • Anisometropia of both eyes C= 2.50D
  • Binocular best corrected visual acuity (BCVA) E= 0.8
  • Agree with the study plan and sign informed consent
  • Study eye is the eye with higher spherical equivalent if both eyes meet criteria, or the eligible eye if only one eye qualifies
Not Eligible

You will not qualify if you...

  • Used or currently using orthokeratology, multifocal contact lenses, defocusing framework lenses, atropine eye drops, or other myopia control treatments in the past month
  • Used red light treatment in the past
  • Children with obvious strabismus or amblyopia
  • Presence of congenital eye diseases such as congenital cataract or congenital retinal disease
  • Secondary myopia caused by other eye diseases or systemic syndromes like Marfan syndrome
  • History of internal eye surgery including cataract extraction or glaucoma surgery
  • Refractive medium opacity including corneal disease or crystal opacity
  • Abnormal intraocular pressure (IOP <10 mmHg or >21 mmHg or binocular difference E 5 mmHg)
  • Fundus chorioretinopathy except high myopia-related degenerative changes or other intraocular diseases
  • Optic nerve damage or congenital optic nerve dysfunction
  • Inability to attend regular check-ups
  • Adjustment range less than 8D or obvious near vision difficulties
  • Other reasons deemed unsuitable by the researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China, 120120

Actively Recruiting

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Research Team

M

Meinan He

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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