Status:
RECRUITING
Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control
Lead Sponsor:
Ruihua Wei
Collaborating Sponsors:
Beijing Tongren Hospital
Conditions:
Myopia
Eligibility:
All Genders
6-12 years
Phase:
PHASE1
PHASE2
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 myop...
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 ran...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT06523504
Start Date
February 1 2024
End Date
March 31 2026
Last Update
September 8 2025
Active Locations (1)
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1
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China, 120120