Myopia
Conditions
Interventions
Combination therapy group:Combination of multifocal soft lens and 0.04% low-concentration atropine
Low-concentration atropine treatment group:0.04 % low concentration atropine eye drops alone
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1) Age from 6 to 18 years old (inclusive). 2) High myopia (equivalent spherical =- 6.0D), with annual progress exceeding -0.75d. 3) Children with good hygiene habits and agree to wear contact lenses during the day. 4) General health status is good, and there are no eye diseases and systemic diseases other than high myopia. 5) Agree to fulfill the follow-up schedule, and be able to abide by all the appointments stipulated in the research protocol during the research period. 6) Subject and guardian understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Wear contact lens, orthokeratology lens or other types of contact lens at present or within 3 months. 2)Use bifocal spectacles, progressive multi-focal spectacles, atropine, pirenzepine or any other myopia control treatment at present or within 3 months. 3) Frequently use eye drops and artificial tears. 4) Systemic medicine currently used may significantly affect the wearing of contact lenses, tear film formation, pupil size, adaptability or refractive status. 5) Known allergy to atropine, fluorescein, benomyl, procaine or tropinamide. 6) Have a clinical history of corneal hypoxia, keratohelcosis, corneal infiltration, viral or fungal infection of eyes or other recurrent keratitis. 7 ) When wearing distance correction at far ( 4 meters ) or near ( 40 centimeters ), squint was found by covering and covering experiment. 8 ) Systemic or ocular diseases affecting eye health. 9 ) Other eye diseases : glaucoma, cataract, keratoconus, irregular cornea, recurrent keratitis, etc. 10 ) suffering from systemic diseases heart disease, rheumatic immune disease, connective tissue disease. 11 ) patients who were participating in or had participated in clinical trials of other drugs or medical devices within two months before this trial. 12 ) Other conditions that the researchers considered inappropriate for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spherical equivalent;Axial length; | — |
Secondary
| Measure | Time frame |
|---|---|
| OCTA;Slit lamp examination;Corneal topography;Eye biomechanics;Fundus photography;Best corrected visual acuity;Presenting vision; | — |
Countries
China
Contacts
Public ContactYue Qi
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed