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Objective: to evaluate the efficacy of different concentrations of atropine eye drops in controlling the progression (diopter, axial length) of high myopia in young children, and to compare the compliance, adverse reaction and regression rate of different concentrations of atropine eye drops in myopia control.
Intervention: Group 1 (0.01% atropine group), Group 2 (0.04% atropine group), Group 3 (0.1% atropine group). During the 2-year intervention period after entering the group, each concentration of atropine eye drops were given every night at a fixed time before going to bed, one drop each time, implemented by parents (supervision), and the wechat small program was completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | 0.01% atropine |
|
| Group 2 | Experimental | 0.04% atropine |
|
| Group 3 | Experimental | 0.1% atropine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine | Drug | different concentrations (0.01%/0.04%/0.1%) of atropine were administered to high myopic children |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of spherical equivalent | Spherical equivalent as measured by cycloplegia autorefraction | at least 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in axial length | AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster or Lenstar | at least 2 years |
| Best corrected vision acuity (BCVA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xun Xu, MD | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Eye Disease Prevention & Treatment Center | Shanghai | Shanghai Municipality | 200040 | China | ||
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BCVA were measured at 4 meters by trained optometrists using the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart
| at least 2 years |
| Intraocular pressure (IOP) | Intraocular pressure (IOP) is measured using a non-contact tonometer, with the average of three consecutive measurements taken. | at least 2 years |
| Pupil size | Photopic and mesopic pupil diameters were measured using a handheld device (VIP-300, NeurOptics) after a 2-minute light adaptation and a 5-minute dark adaptation, respectively | at least 2 years |
| Accommodative function | Positive/negative relative accommodation (PRA/NRA) were performed at a distance of 40 cm | at least 2 years |
| Shanghai General Hospital |
| Shanghai |
| China |
| Shanghai Ninth People's Hospital | Shanghai | China |
| ID | Term |
|---|---|
| D001285 | Atropine |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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