myopia
Conditions
Interventions
Experimental group A:Wearing Pro defocal lenses
Experimental group B:Wearing Max-2 defocal lenses
Sponsors
Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Age range from 6 to 12 years (inclusive), regardless of gender; 2. When screening, the binocular myopia, spherical equivalent (SE) -0.50D to -6.00D (automatic optometry after Ciliary muscle paralysis); 3. When screening, the astigmatism of both eyes after Ciliary muscle paralysis was detected by computer optometry <= 1.50D; 4. When screening, the anisometropia (calculated based on equivalent spherical diopter) is less than 1.50D; 5. Any intraocular pressure<21mmHg; 6. When screening, the best corrected far vision for any eye should reach at least 5.0 logarithmic vision; 7. Obtain the written informed consent jointly signed by the Legal guardian or the child and the Legal guardian.
Exclusion criteria
Exclusion criteria: 1. Any eye has a current or previous history of dominant strabismus (including intermittent strabismus, and the Dispersive prism test strabismus degree is greater than 15 prism degrees) and amblyopia; 2. Any disease or syndrome history that may lead to severe myopia (such as Marfan syndrome, Stickler syndrome, Retinopathy of prematurity, etc.); 3. The refractive medium of any eye is abnormal (such as Keratoconus, conus lens, spherical lens, etc.); 4. Any eye with glaucoma or angle stenosis or previous medical history; 5. Having or having a history of severe corneal injury; 6. Any eye surgery or laser treatment history (except eye surgery that has no impact on the development of refractive system such as eye face and conjunctiva); 7. I have used other myopia control treatment methods other than this study in the first 6 months of screening, such as corneal shaping lenses, multifocal soft lenses, etc; 8. Any local or systematic anti poisonous oxaline/anticholinergic drugs (such as Atropine, Scopolamine, tropicamide, etc.) that are used for a long time within 21 days before screening and the expected whole study period (that is, more than 7 consecutive days in a month or more than 30 days in a year in total) are allowed to be used for optometry and other examinations; 9. Serious systemic diseases that the researchers believe are not suitable for participation in this study; 10. Participate in other clinical trials within 30 days before screening; 11. Currently using Atropine, OK lens or any other treatment method to control myopia; 12. Use eye medicines and artificial tears regularly; 13. Only those who meet the inclusion criteria for one eye; 14. Poor compliance and inability to seek medical attention in a timely and regular manner as required; 15. Other researchers believe that it is not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in cycloplegic spherical equivalent; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comprehensive refraction(near phoria degree, AC/A, NRA, PRA and BCC);Contrast sensitivity;Accommodative facility;Amplitude of accommdation;Binocular parallax;Multispectral refractive topography;Changes in axial length;Changes in corneal curvature;Changes in anterior chamber depth; | — |
Countries
China
Contacts
Public ContactBi Hongsheng
Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine
Outcome results
None listed