NCT06523504 Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control
| NCT ID | NCT06523504 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Ruihua Wei |
| Condition | Myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 410 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 410 participants in total. It began in 2024-02-01 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06523504 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 12 Years, studying Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06523504 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06523504 currently recruiting?
Yes, NCT06523504 is actively recruiting participants. Contact the research team at hmn509@tmu.edu.cn for enrollment information.
Where is the NCT06523504 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06523504 clinical trial?
NCT06523504 is sponsored by Ruihua Wei. The trial plans to enroll 410 participants.