NCT06926556CompletedNot Applicable
Different Microlenses Array for Controlling Myopia Progression in Children and Adolescents
Shanghai Eye Disease Prevention and Treatment Center1 site in 1 country134 target enrollmentStarted: August 1, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Subjective refraction equivalent spherical
Study Overview
Brief Summary
This study aims to evaluate the effectiveness of lenses with different defocused microlens array in controlling the progression of myopia in children and adolescents, and to explore the feasibility of effective defocus microlens design, and apply personalized defocus frame lenses for myopia prevention and control.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 6 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: 6-14 years old;
- •After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within -0.50D~-4.00D, binocular cylinder power ≤ 1.50D, the anisometropia is less than 1.50D, and the best corrected visual acuity was above 5.0;
- •Within 30 days, 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
- •Diagnosed constant strabismus;
- •Diagnosed pathological myopia;
- •Other congenital eye diseases;
- •Researchers believe that the patients have other reasons that are not suitable for inclusion in the project.
Arms & Interventions
H.M.E.C，High Precision Micro Encircle
Experimental
Intervention: Defocus microlenses (Device)
H. A. L. T, highly aspheric lenslet technology
Active Comparator
Outcomes
Primary Outcomes
Subjective refraction equivalent spherical
Time Frame: 2 years
Secondary Outcomes
- Axial length(2 years)
Investigators
Study Sites (1)
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