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Peripheral contact lens in controlling myopia progression in high myopia children（PAM）is a prospective, single-center, randomized controlled trial with three parallel arms conducted at Beijing Tongren Hospital. Chinese children aged 6-12 years with high myopia (spherical equivalent ≤-6.0D) and annual progression ≥0.75D will be enrolled. Participants will be randomized 40:40:40 to: (1) combination therapy group receiving atropine 0.04% plus soft peripheral defocus contact lenses; (2) atropine monotherapy group receiving atropine 0.04% plus spectacles; or (3) control group receiving atropine 0.01% plus spectacles. The primary outcome is change in axial length and cycloplegic refraction at 24 months. Secondary outcomes include changes in pupil diameter, and safety parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combination therapy group | Experimental | 40 patients in combination therapy group received atropine 0.04% plus soft peripheral defocus contact lenses |
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| atropine monotherapy group | Experimental | 40 patients in atropine monotherapy group received atropine 0.04% plus spectacles |
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| control group | Placebo Comparator | 40 patients in control group received atropine 0.01% plus spectacles |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soft peripheral defocus contact lenses | Device | Multifocal soft contact lenses with peripheral defocus design have shown promise in reducing axial elongation. They work by reducing peripheral hyperopic defocus, which is thought to drive eye growth |
| Measure | Description | Time Frame |
|---|---|---|
| Axial length elongation | Axial length will be measured using the IOLMaster 500 optical biometry system (Carl Zeiss Meditec, Jena, Germany). To ensure measurement reliability and minimize random error, five consecutive measurements will be obtained for each eye at each visit, with individual measurements required to have a signal-to-noise ratio ≥2.0. The mean value of these five measurements will be calculated and used for analysis. Measurements will be standardized by time of day, conducted between 1:00 PM and 5:00 PM at all visits to minimize the influence of diurnal variations in axial length. | from baseline to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cycloplegic spherical equivalent refraction | The change in spherical equivalent refraction (SE = sphere + cylinder/2) under cycloplegia, measured from baseline. Cycloplegia will be induced using compound tropicamide eyedrops per a standardized protocol and confirmed by pupil diameter (≥6 mm) and light reflex assessment. Refraction will then be measured using an autorefractor (Topcon KR-8800). Five measurements will be taken per eye, and the mean SE will be calculated from readings with a divergence of less than 0.25 D. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Eye Center, Beijing Tongren Hospital | Beijing | China |
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Generation of random sequences, determination of random number grouping, and inclusion of subjects by different staff members.
| Atropine 0.04% | Drug | Low-concentration atropine eyedrops (atropine 0.04% and atropine 0.01% used in this trial) are the only consistently effective pharmacological treatment for myopia control |
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| Atropine (0.01%) | Drug | Low-concentration atropine eyedrops (atropine 0.04% and atropine 0.01% used in this trial) are the only consistently effective pharmacological treatment for myopia control |
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| Single Vision Spectacles | Device | Single Vision Spectacles are the most commonly used device in high myopia children, which demonstrate better pediatric compliance, eliminate infection risks, and involve lower long-term costs. |
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| Baseline, 6 months, 12 months, 18 months, and 24 months. |
| 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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