Myopia in children and adolescents
Conditions
Interventions
Experimental Group:Bendazol eye drops were atomized
Control group:The blank solvent atomization
Sponsors
Ineye Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
8 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Age of 8-12 years old, male or female; 2. It is consistent with the clinical diagnosis of low and moderate simple myopia in both eyes, and the optometry of tropicamide cycloplegia has a spherical power of <=-0.50D; 3. astigmatism <= 1.50D; 4. The best corrected visual acuity of both eyes was greater than or equal to 1.0; 5. A written informed consent signed by the child and legal guardian has been obtained; 6. If both eyes of the patient meet the inclusion criteria, the dominant eye was determined as the target study eye.
Exclusion criteria
Exclusion criteria: 1. Bendazol allergy or herpes simplex virus infection; 2. IOP of any eye >= 21 mmHg; 3.Any eye disease that affects vision or ametropia (such as cataract and other lens injury diseases, dominant strabismus, glaucoma, corneal lesions, macular degeneration, uveitis, retinal detachment, severe vitreous opacity, etc.); 4. Active periocular or ocular inflammation (such as blepharitis, infectious conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye; 5. General conditions that may affect refractive development (such as Down syndrome and Marfan syndrome); 6. Anyone with hyperopia of >=+0.50D; 7. Anyone with corneal curvature abnormality such as keratoconus; 8. Patients with anisometropia (the difference in diopter between eyes is >=-1.50D for spherical lens and >=-1.00d for cylindrical lens); 9. Patients with uncontrolled systemic diseases or debilitating diseases and immune deficiency; 10. Those who underwent eye surgery within 3 months before screening; 11. Those who plan to undergo eye surgery within 6 months; 12. Those who plan to use orthokeratology lens, rigid contact lens and multifocal progressive lens for vision correction within 6 months; 13. Have used myopia control treatment methods other than monocular frame glasses within 6 months before joining the group, such as atropine or pirenzepin; Instrument therapy: orthokeratology, multifocal soft lens, multifocal hard lens and functional frame glasses; 14. Systemic or local use of drugs that affect the efficacy evaluation within 3 months before screening, such as anticholinergic drugs: atropine and pirenzepin; Cholinemimetics: pilocarpine, etc. 15. Clinical researchers who have participated in other drugs within 3 months before screening. 16. Persons deemed by the investigator to be unfit to participate in a clinical trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in cycloplegic refraction of tropicamide; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in axial length from baseline;Change from baseline in subfoveal choroidal thickness;Change from baseline in retinal oxygen saturation;Change from baseline in pupil diameter;Change in corneal curvature from baseline;Change in anterior chamber depth from baseline;Change from baseline in vitreous cavity depth;Change from baseline in choroidal blood flow;Incidence of adverse events (ocular or nonocular);Eye examination: including intraocular pressure, ocular inflammation, ocular infection, and ocular bleeding; | — |
Countries
China
Contacts
Public ContactAirui Xie
Ineye Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed