Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control
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
Ruihua Wei
410 participants
Feb 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria12
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
wear DIMS ,and use placebo,once nightly, both eye
wear SP, and use 0.02%ATP eye drops, once nightly, both eye
wear SP, and use 0.04%ATP eye drops, once nightly, both eye
wear DIMS, and use 0.02%ATP eye drops, once nightly, both eye
wear DIMS, and use 0.04%ATP eye drops, once nightly, both eye
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06523504