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| Name | Class |
|---|---|
| People's Hospital of Guangxi | UNKNOWN |
| Henan Provincial People's Hospital | UNKNOWN |
| Tianjin Medical University Eye Hospital | OTHER |
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The purpose of this multicenter randomized clinical trial is to evaluate the myopia control effect of orthokeratology and 0.01% atropine sequential treatment in children and adolescents, as compared to continuous treatment with orthokeratology.
Myopia constitutes a major threat to vision health globally for its increasing prevalence and irriversible blinding complications. It is crucial to effectively intervene subjects with progressive myopia to reduce risks of myopic pathologies in later life.
Orthokeratology (ortho-k) is the first-line intervention for myopia control, with an efficacy of slowing axial elongation by 43-63%. However, the efficacy decreases over time. Sequential treatment strategy, which switches myopia control interventions at some intervals, has a potential to increase myopia control efficacy regarding the whole treatment period, compared to applying one intervention throughout. However, there lacks evidence supporting the benefit of this treatment strategy.
The purpose of this study is to evaluate the effectiveness of orthokeratology and 0.01% atropine sequential treatment on myopia control in children and adolescents, as compared to continuous treatment with orthokeratology, using a multicenter randomized controlled trial design. Subjects will be randomly assigned into either ortho-k and 0.01% atropine sequential treatment group or ortho-k continuous treatment group. Their axial length will be monitored over two years. Changes in axial length in the two groups will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ortho-k and 0.01% atropine sequential treatment | Experimental | Participants will be treated with ortho-k lenses during the first year, and swiched to recieve 0.01% atropine twice a day in the second year. |
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| Ortho-k continuous treatment | Active Comparator | Participants will be treated with ortho-k lenses throughout, during the 2-year study period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ortho-k lenses | Device | Ortho-k lenses will be administered nightly. |
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| Measure | Description | Time Frame |
|---|---|---|
| Axial length change | Axial length change (mm) is characterized as the difference between 25-month follow-up visit and baseline values. The IOLMaster or Lenstar are used to measure axial length (mm). | From baseline to the end of treatment at 25 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of rapid myopia progression | Proportion of rapid myopia progression means the rate of cumulative axial growth ≥0.50 mm at 25 months) after intervention. | From baseline to the end of treatment at 25 months |
| Axial length change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yin Hu, Doctor | Contact | 86-18664783831 | eddy06980094@163.com | |
| Xiao Yang, Professor | Contact | 86-13760766303 | yangx_zoc@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| 0.01% Atropine | Drug | 0.01% Atropine will be administrated twice a day with an interval of about 12 hours. Drop into the conjunctival sac and immediately compress the lacrimal sac of the inner canthus for 2-3 minutes. |
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Axial length change (mm) is characterized as the difference between 3, 6, 9, 12, and 19 months follow-up visit and baseline values. The IOLMaster or Lenstar are used to measure axial length (mm).
| From baseline to 3, 6, 9, 12, and 19 months. |
| Incidence of adverse events | Incidence of adverse events is the rate of adverse events over the study period for subjects in both arms. | From baseline to 25 months. |
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |