Myopia
Conditions
Interventions
test group:Dibazole eye drops nebulized
control group:0.01% atropine eye drops
Sponsors
Bejing Tongren Hospital, Capital Medical Uniersity
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1.Age 6~12 years old (including 6 years old and 12 years old); 2.Cycloplegia refraction (equivalent spherical diopter) is between -0.50D to -4.50D (including the boundary value), and the cylinder diopter is <= -1.50D (monoocular compliance can also be included in the group); 3.Binocular anisometropia <2.00D (spherical aberration <1.50D, cylindrical aberration <1.00D); 4.The best corrected visual acuity of both eyes is 0.8 or better; 5.Corneal curvature of both eyes is 40.00-46.00D; 6.Intraocular pressure 10~20mmHg; 7.Those who have obtained the informed consent of the legal guardian, the informed consent of the child, and who can conduct the experiment according to the requirements of the program;
Exclusion criteria
Exclusion criteria: 1.People who are allergic to dibazole and (or) herpes simplex virus infection; 2.People with atropine allergy and/or glaucoma and glaucoma predisposition, allergy to scopolamine components and with traumatic brain injury; 3.Eye diseases affecting vision or refractive error (such as cataract and other lens damage diseases, dominant strabismus, glaucoma, keratopathy, macular degeneration, uveitis, retinal detachment, severe vitreous opacity, ptosis, etc.); 4.Active periocular or ocular inflammation in either eye (eg, blepharitis, infectious conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis); 5.Persons with systemic conditions that may affect refractive development (eg Down syndrome, Marfan syndrome); 6.Hyperopia with >= 0.50D in either eye; 7.Those with abnormal corneal curvature such as keratoconus in any eye; 8.Patients with uncontrolled systemic disease or debilitating disease and immunodeficiency; 9.Those who received eye surgery 4 weeks before screening; 10.Participate in clinical investigators of other drugs or devices within 4 weeks before screening; 11.Use of myopia control treatment methods other than monofocal frame glasses within 4 weeks before enrollment, drug treatment: such as atropine or pirenzepine; device treatment: orthokeratology lens, multifocal soft lens, multifocal hard lens Glasses, functional frame glasses; 12.Those with poor compliance with return visits; 13.Plan to have other ophthalmic operators before completing the final study evaluation; 14.Myopia and Xianwu eye drops are used within 4 weeks before screening or during the trial; 15.Dry eye or Meibomian gland dysfunction; 16.There are other circumstances that the investigator considers unsuitable to participate in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spherical Equivalent(SE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Tear Break-Up Time(BUT);Uncorrected Visual Acuity(SC);Axial Length;Accommodative Sensitivity;Spherical Equivalent(SE);Choroidal thickness; | — |
Countries
China
Contacts
Public Contactwangningli
Bejing Tongren Hospital, Capital Medical Uniersity
Outcome results
None listed