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New treatment option for Myopia
Official title Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control
ClinicalTrials.gov ID: NCT06523504
What this study is testing
What is The 0.02% ATP Group?
The 0.02% ATP Group is an investigational medicine, being studied as a potential treatment for myopia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 12
You may be able to join if
- 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...
- 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 , the eye with higher spherical equivalent is the study eye; if one eye meets the , the eye is the study eye.
You likely can't join if
- Used or currently using orthokeratology, multifocal contact lenses, defocusing framework lenses, atropine eye drops and other myopia control means in...
- 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...
- 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.)
See the full eligibility 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...
- 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 , the eye with higher spherical equivalent is the study eye; if one eye meets the , the eye is the study eye.
- 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 \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.