NCT07284147Enrolling By InvitationNot Applicable
Clinical Study on the Control Effect of 3D Designed Defocus Lenses on Myopia in Children and Adolescents
Shanghai Eye Disease Prevention and Treatment Center1 site in 1 country144 target enrollmentStarted: September 1, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Subjective refraction equivalent spherical
Study Overview
Brief Summary
This study aims to evaluate the effectiveness of lenses with 3D Designed Defocus in controlling the progression of myopia in children and adolescents, and to explore the feasibility of effective design, and apply personalized frame lenses for myopia prevention and control.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age: 6-14 years old; After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within -0.40D~-4.00D, binocular cylinder power ≤ 1.50D, the anisometropia is ≤ 1.50D, the progression of myopia in the past year is greater than 0.5D, the best corrected far vision is at least 4.8, and the near vision is at least 5.0; Within 3 months, the myopia prevention and control methods such as multifocal glasses, orthokeratology, defocusing flexible glasses, progressive glasses, atropine eye drops, red light and acupuncture and moxibustion treatment were not used; The subject has a willingness to receive treatment and an informed consent form is signed by their legal guardian.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Subjective refraction equivalent spherical
Time Frame: 12 months
Subjective refraction equivalent spherical
Secondary Outcomes
- Axial length(12 months)
- Choroidal thickness(12 months)
Investigators
Study Sites (1)
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