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

Launched by RUIHUA WEI · Jul 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of two treatments to help control myopia, also known as nearsightedness, in children. The treatments being tested include low concentration atropine eye drops and a special type of lens called DIMS, which is designed to help reduce the progression of myopia. The goal is to see how well these treatments work together to prevent further changes in eye length and vision in children aged 6 to 12 years who have moderate to high myopia.

To participate in this study, children must meet certain criteria, such as having a specific level of nearsightedness and being able to see well with corrected vision. Participants will receive regular check-ups to monitor their eye health and vision throughout the trial. This study is currently looking for eligible children to join, and it is essential that participants do not use other myopia treatments before or during the trial. Overall, this research aims to find better ways to manage myopia in children, which can help improve their long-term vision health.

Gender

ALL

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 \<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