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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device, Combination product
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Tianjin Medical University Eye Hospital
RECRUITING
Tianjin
Contact Information
Primary
Meinan He
hmn509@tmu.edu.cn
+8613672135765
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 410
Treatments
Experimental: The DIMS Group
wear DIMS ,and use placebo,once nightly, both eye
Experimental: 0.02% ATP
wear SP, and use 0.02%ATP eye drops, once nightly, both eye
Experimental: 0.04%ATP
wear SP, and use 0.04%ATP eye drops, once nightly, both eye
Experimental: 0.02%ATP+DIMS
wear DIMS, and use 0.02%ATP eye drops, once nightly, both eye
Experimental: 0.04%ATP+DIMS
wear DIMS, and use 0.04%ATP eye drops, once nightly, both eye
Related Therapeutic Areas
Sponsors
Leads: Ruihua Wei
Collaborators: Beijing Tongren Hospital

This content was sourced from clinicaltrials.gov