Status:
ENROLLING_BY_INVITATION
Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses
Lead Sponsor:
Shanghai Eye Disease Prevention and Treatment Center
Conditions:
Myopia, Progressive
Eligibility:
All Genders
6-14 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT06221592
Start Date
March 1 2024
End Date
December 31 2026
Last Update
October 1 2024
Active Locations (1)
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1
Shanghai Eye Diseases Prevention &Treatment Center/ Shanghai Eye Hospital, School of Medicine, Tongji University
Shanghai, Shanghai Municipality, China, 200050