Clinical trial NCT06523504: Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Myopia
Lead sponsor: Tianjin Medical University Eye Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tongren Hospital
First posted: 2024-07-26
Enrollment: 410
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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 \&lt;10 mmHg or IOP \&gt;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

Primary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Tianjin
Study officials:
References: