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| Name | Class |
|---|---|
| The University of Hong Kong | OTHER |
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Our project is a 24-month longitudinal randomized controlled trial that aims to investigate the myopia development after topical application of 0.01% atropine in children with either fast or slow myopia progression classified according to their initial electro-retinal responses. This will help elucidate the effectiveness of using low concentration atropine for myopia control in children with different myopia progression rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atropine 0.01% | Experimental | Group receiving atropine treatment for 18 months |
|
| Artifical tear | Placebo Comparator | Group receiving placebo for 18 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine (0.01%) | Drug | tropical application |
| |
| Artificial tear |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Changes in Refractive Error (SER) | Annualized changes in refractive error (SER) after receiving the 0.01 atropine or artificial tears up to 18 months | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Change in Axial Length | Annualized change in axial length after receiving the 0.01 atropine or artificial tears up to 18 months | 18 months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry HL CHAN, PhD | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Optometry, Hong Kong Polytechnic University | Hong Kong | 00000 | Hong Kong |
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Recruitment period: Feb 2018 - Oct 2018 Location: HK PolyU Optometry clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Atropine 0.01% | Group receiving atropine treatment for 18 months Atropine (0.01%): tropical application |
| FG001 | Artifical Tear | Group receiving placebo for 18 months Artificial tear: tropical application |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atropine 0.01% | Group receiving atropine treatment for 18 months Atropine (0.01%): tropical application |
| BG001 | Artifical Tear | Group receiving placebo for 18 months Artificial tear: tropical application |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 2 subjects from treatment group and 8 subjects from control group withdrew from the study |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Annualized Changes in Refractive Error (SER) | Annualized changes in refractive error (SER) after receiving the 0.01 atropine or artificial tears up to 18 months | Annualized changes in refractive error (SER) | Posted | Mean | Standard Deviation | Dioptre/year | 18 months |
|
18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atropine 0.01% | Group receiving atropine treatment for 18 months Atropine (0.01%): tropical application |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Henry Chan | HK Polytechnic University | +85227667937 | henryhl.chan@polyu.edu.hk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 1, 2018 | Oct 10, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 1, 2018 | Oct 10, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 2, 2018 | Aug 18, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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Randomized clinical trial
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Double-blinded
| Drug |
tropical application |
|
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | 2 subjects from treatment group and 8 subjects from control group withdrew from the study | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | 2 subjects from treatment group and 8 subjects from control group withdrew from the study | Number | participants |
|
| Refractive errors | 2 subjects from treatment group and 8 subjects from control group withdrew from the study | Mean | Standard Deviation | Dioptre |
|
| Electroretinogram | Induced response from central retina measured by multifocal electroretinogram | 2 subjects from treatment group and 8 subjects from control group withdrew from the study | Mean | Standard Deviation | nV/deg^2 |
|
| Axial length | 2 subjects from treatment group and 8 subjects from control group withdrew from the study | Mean | Standard Deviation | mm |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Annualized Change in Axial Length | Annualized change in axial length after receiving the 0.01 atropine or artificial tears up to 18 months | annualized change in axial length | Posted | Mean | Standard Deviation | mm/year | 18 months |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Artifical Tear | Group receiving placebo for 18 months Artificial tear: tropical application | 0 | 27 | 0 | 27 | 0 | 27 |
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| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |