Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China, 120120
Actively Recruiting
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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