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

Ruihua Wei

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Myopia

Treatments: Combination Product: 0.02%ATP+DIMS; Drug: The 0.04% ATP Group; Drug: The 0.02% ATP Group; Device: DIMS; Combination Product: 0.04%ATP+DIMS

Study type: Interventional

Funder types: Other

Identifiers

NCT06523504

2019yj001J-5 (Other Grant/Funding Number)

Details and patient eligibility

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.

Full 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.

Enrollment: 410 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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 <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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

410 participants in 5 patient groups

The DIMS Group

Experimental group

Description:

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

Treatment:

Device: DIMS

0.02% ATP

Experimental group

Description:

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

Treatment:

Drug: The 0.02% ATP Group

0.04%ATP

Experimental group

Description:

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

Treatment:

Drug: The 0.04% ATP Group

0.02%ATP+DIMS

Experimental group

Description:

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

Treatment:

Combination Product: 0.02%ATP+DIMS

0.04%ATP+DIMS

Experimental group

Description:

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

Treatment:

Combination Product: 0.04%ATP+DIMS