Myopia
Conditions
Interventions
Experimental group (0.01% atropine sulfate eye drops):1 drop in each eye, once a day, every night before going to bed, gently press the dacryocyst on both sides for about 1 minute.
Experimental group (0.02% atropine sulfate eye drops):1 drop in each eye, once a day, every night before going to bed, gently press the dacryocyst on both sides for about 1 minute.
Control group (atropine sulfate eye drops placebo):1 drop in each eye, once a day, every night before going to bed, gently press the dacryocyst on both sides for about 1 minute.
Sponsors
Beijing Tongren Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Participants who meet all of the following criteria will be eligible to participate in the study. 1. The legal guardian of the subject shall sign the written informed consent voluntarily, and the subject > 8 years old shall sign the informed consent voluntarily. 2. Patients with myopia aged 6 to 12 years (including the critical value). 3. At the time of screening, both eyes were nearsighted, and the equivalent bulb degree was -1.00D to -4.00D (automatic computer optometry after ciliary muscle paralysis). 4. Binocular astigmatism <= 1.50D was detected by computer optometry after ciliary muscle paralysis during screening. 5. Anisometropia (measured by equivalent spherical degree) < 2.00D during screening. 6. Be able to comply with study requirements, participate in all study visits (including telephone visits), and be willing to receive randomized treatment with atropine or placebo.
Exclusion criteria
Exclusion criteria: Exclusion criteria: Patients who meet any of the following exclusion criteria will not be enrolled in this study. 1. Allergic to this product or its excipients. 2. Patients with eye diseases that may affect vision (such as lens diseases such as cataract, glaucoma, fundus macular disease, keratopathy, pigmentitis, retinal detachment, severe vitreous opacity, dominant strabismus, nystagmus, acute ocular inflammatory diseases), Recurrent history of chronic inflammation of the eye or any other pathological changes in the eyeball (such as narrow Angle, anterior chamber too shallow). 3. The best corrected distant visual acuity of any eye can not reach 4.9 or above logarithmic visual acuity during screening. 4. Intraocular pressure > 21 mmHg or 120 times/score, and the screening fails). 12. The need for ocular or systemic oral corticosteroids is expected during the study period. Intranasal, inhalation, topical skin, intra-articular, perianal and short-term oral steroids are permitted (i.e. continuous use for <2 weeks). 13. Other situations deemed unsuitable by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intergroup difference in baseline change in the equivalent spherical degree of electroencephaloscopy following cycloplegia with 0.01% or 0.02% atropine sulfate eye drops versus placebo at W96 visit (0.02% atropine versus placebo; 0.01% atropine versus placebo).; | — |
Secondary
| Measure | Time frame |
|---|---|
| At W96 visit, 0.01% compared with 0.02% atropine sulfate eye drops after cycloplegia, the difference between the baseline values of computer optometry isoeffect spheroscope;;Intergroup differences in changes in axial length from baseline at W96 visits (0.02% atropine versus placebo; 0.01% atropine versus placebo; 0.02% atropine versus 0.01% atropine);;At W48 visit, the intergroup difference in the change from baseline in the equivalent spherical degree of computer optometry after ciliary paralysis (0.02% atropine vs. placebo; 0.01% atropine versus placebo; 0.02% atropine versus 0.01% atropine);;Intergroup differences in changes in axial length from baseline at W48 visits (0.02% atropine versus placebo; 0.01% atropine versus placebo; 0.02% atropine versus 0.01% atropine);;During the W48 and W96 visits, Intergroup difference in the ratio of subjects with a change in the equivalent spherical degree of computer optometry from baseline = -0.25 D, =-0.50D, =-0.75D, =-1.00D, >-0.50D, >-0.75D, >-1.00D after ciliary muscle paralysis (0.02% atropine vs. placebo; 0.01% atropine versus placebo; 0.02% atropine versus 0.01% atropine);;Intergroup differences in median time to myopia progression (equivalent spherical degree of computer optometry after ciliary paralysis) -0.25D, -0.50D, -0.75D (0.02% atropine vs. placebo; 0.01% atropine versus placebo; 0.02% atropine versus 0.01% atropine);;At W48 and W96 visits, compared with the control group, the progress of equivalent spheroscope was reduced by 30% and 50%, with inter-group differences in the proportion of patients (0.02% atropine versus 0.01% atropine);;Intergroup differences in baseline changes in other morphologic measures of the subjects' eyes (such as corneal curvature, vitreous cavity depth, lens thickness) at W48 and W96 visits (0.02% atropine vs. placebo; 0.01% atropine versus placebo; 0.02% atropine versus 0.01% atropine).; | — |
Countries
China
Contacts
Public ContactNingli Wang
Beijing Tongren Hospital Affiliated to Capital Medical University
Outcome results
None listed