NCT06221592Enrolling By InvitationNot Applicable
Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses in Myopia Prevention and Control
Shanghai Eye Disease Prevention and Treatment Center1 site in 1 country252 target enrollmentStarted: March 1, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 252
- Locations
- 1
- Primary Endpoint
- Axial length
Study Overview
Brief Summary
To evaluate the differences in controlling the progression of myopia in adolescents and the safety and comfort of wearing different types of defocus incorporated multiple segments spectacle lenses, to explore the feasibility of effective defocus micro lens 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
- Single (Participant)
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 0.00D~-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
Full axis multi-point defocus spectacle lenses
Experimental
Intervention: defocus spectacle lenses (Device)
Innovative micro defocus spectacle lenses
Experimental
Intervention: defocus spectacle lenses (Device)
Circular multi-point optical micro transparent defocus spectacle lenses
Experimental
Intervention: defocus spectacle lenses (Device)
High non spherical micro transparent defocus spectacle lenses
Placebo Comparator
Intervention: defocus spectacle lenses (Device)
Outcomes
Primary Outcomes
Axial length
Time Frame: 2 years
The change of axial length.
Secondary Outcomes
- Subjective refraction equivalent spherical(2 years)
Investigators
Study Sites (1)
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