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

ConditionMyopia

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age6-12

SponsorRuihua Wei

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

DIMS
Device
wear DIMS ,and use placebo,once nightly, both eye
The 0.02% ATP Group
Drug
wear SP, and use 0.02%ATP eye drops, once nightly, both eye
The 0.04% ATP Group
Drug
wear SP, and use 0.04%ATP eye drops, once nightly, both eye
0.02%ATP+DIMS
Combination product
wear DIMS, and use 0.02%ATP eye drops, once nightly, both eye
0.04%ATP+DIMS
Combination product
wear DIMS, and use 0.04%ATP eye drops, once nightly, both eye

Treatment groups

410 Participants

are divided into 5 treatment groups

Group A: The DIMS GroupExperimental treatment 1 intervention

Group B: 0.02% ATPExperimental treatment 1 intervention

Group C: 0.04%ATPExperimental treatment 1 intervention

Group D: 0.02%ATP+DIMSExperimental treatment 1 intervention

Group E: 0.04%ATP+DIMSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Best Corrected Visual Acuity

Time frame

up to 24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruihua Wei

Lead sponsor

Tianjin Medical University Eye Hospital

Sponsor institution

Beijing Tongren Hospital

Collaborator

Source ClinicalTrials.gov

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