Nearsightedness
Conditions
Interventions
Test group 2:Fitted with Puno pupil defocusing soft mirror
Test group 1:Fitted with Puno pupil series defocusing frame mirror
Control group:Fitting ordinary single lens
Sponsors
Bejing Tongren Hospital, Capital Medical Uniersity
Eligibility
Sex/Gender
All
Age
8 Years to 15 Years
Inclusion criteria
Inclusion criteria: 1.Age 8 to 15 years old, male or female; 2.The objective optometric equivalent spherical degree (SE) of both eyes after cycloplegia ranged from -0.50D to -10.00D (including -0.5D and -10.00D), astigmatism 3:1; 0.75D 4:1.); 3.The best corrected vision at either glance is 1.0 or better; 4.Except for refractive errors, there were no abnormalities or diseases in both eyes; 5.During the study period, the lens wearing requirements should be followed (at least 12 hours per day, 8-10 hours for the defocusing soft lens group), and the investigator should be notified of any interruption; 6.The patient is willing to complete the visit and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of ocular trauma or surgery within 8 weeks prior to inclusion in this test; 2.Dominant strabismus or abnormal binocular vision; 3.Patients who are using or need to use drugs that may cause dry eyes or affect vision (e.g., penicillin, streptomycin, chloramphenicol, sulfonamides, isoniazid, etc.) during the follow-up study; 4.People with systemic diseases; 5.The subjects exhibited poor personal hygiene; 6.Known allergy to fluorescein, aubucaine, promecaine, or topicamide; 7.Soft contact lenses should not be worn in living or learning environments, such as airborne dust, pharmaceuticals, aerosols (such as hair gels, volatile substances), dust, etc; 8.He has a variety of eye diseases, such as acute or chronic inflammation of the eye, glaucoma, abnormal corneal perception, keratoconus, irregular cornea, corneal epithelial defect, severe dry eye, etc; 9.Other products to delay myopia progression were used in the 3 months before and during the wearing test, such as specially designed myopia control lenses (including frame glasses, OK glasses, RGP, multifocal contact lenses, progressive multifocal lenses, etc.), atropine drugs, repeated low-intensity red light irradiation, etc; 10.Use any systemic or topical ophthalmologic medications or over-the-counter artificial tears that interfere with the fitting of soft contact lenses, tear film production, pupil size, adjustment, refractive status, or require lens removal during the day; 11.Other conditions deemed unsuitable for inclusion by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spherical equivalent; | — |
Secondary
| Measure | Time frame |
|---|---|
| Axial length of eye; | — |
Countries
China
Contacts
Public ContactLei Tian, Ying Jie
Bejing Tongren Hospital, Capital Medical Uniersity
Outcome results
None listed