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| Name | Class |
|---|---|
| Hoya Vision Care | INDUSTRY |
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The purpose of this study is to determine if the Multiple-Segment (MS) spectacle lens can slow myopia progression in Hong Kong schoolchildren.
MS lens is also called Defocus Incorporated Multiple Segments (DIMS) spectacle lens
MS lens is a novel lens designed in attempt to slow myopia progression. It is a multifocal spectacle lens which corrects distance refractive error and at the same time produces myopic defocus images on the retina for all distances. The myopic defocus aims at slowing down myopia progression. The purpose of this study is to investigate if the MS lens can slow myopia progression in Hong Kong Chinese schoolchildren. The subjects will be randomly assigned to either treatment group (wear MS lenses) or control group (wear ordinary single vision lenses). Their cycloplegic refraction and axial length will be monitored every six months over 2 years. The changes in refractive errors and axial length in two groups will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single vision spectacle lens | No Intervention | Single vision lens with power for correcting distance refraction. | |
| Multiple-Segment spectacle lens | Experimental | A multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple-Segment spectacle lens | Device | A multifocal spectacle lens that corrects distance refraction and provides myopic defocus images simultaneously. The myopic defocus aims at slowing down myopia progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Cycloplegic Refraction Change in SER | Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor. | Baseline and 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Axial Length | Axial length (mm) was measured after cycloplegia using IOL Master | Baseline and 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carly SY Lam, PhD | The Hong Kong Polytechnic University | Principal Investigator |
| Chi ho To, PhD | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Myopia Research, The Hong Kong Polytechnic University | Hong Kong | China | ||||
| Centre for Myopia Research, The Hong Kong Polytechnic University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31142465 | Result | Lam CSY, Tang WC, Tse DY, Lee RPK, Chun RKM, Hasegawa K, Qi H, Hatanaka T, To CH. Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial. Br J Ophthalmol. 2020 Mar;104(3):363-368. doi: 10.1136/bjophthalmol-2018-313739. Epub 2019 May 29. | |
| 37715201 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Vision Spectacle Lens | Single vision lens with power for correcting distance refraction. |
| FG001 | Multiple-Segment Spectacle Lens | A multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time. Multiple-Segment spectacle lens: A multifocal spectacle lens that corrects distance refraction and provides myopic defocus images simultaneously. The myopic defocus aims at slowing down myopia progression. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Vision Spectacle Lens | Single vision lens with power for correcting distance refraction. |
| BG001 | Multiple-Segment Spectacle Lens | A multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time. Multiple-Segment spectacle lens: A multifocal spectacle lens that corrects distance refraction and provides myopic defocus images simultaneously. The myopic defocus aims at slowing down myopia progression. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Cycloplegic Refraction Change in SER | Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor. | completed 2-year study | Posted | Mean | Standard Deviation | Diopters (D) | Baseline and 2 years |
|
|
6 months
Interventions were only spectacles, not drug or surgery. The subjects only wore spectacle lenses and had regular routine eye examination that the particpants rarely had risk of adverse events.
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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 | SV Group | single vision spectacle lens | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Carly Sin Yin Lam | School of Optometry, The Hong Kong Polytechnic University | 2766 6091 | carly.lam@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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2014 | Jun 9, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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|
| Hong Kong |
| Hong Kong |
| Chun RKM, Zhang H, Liu Z, Tse DYY, Zhou Y, Lam CSY, To CH. Defocus incorporated multiple segments (DIMS) spectacle lenses increase the choroidal thickness: a two-year randomized clinical trial. Eye Vis (Lond). 2023 Sep 15;10(1):39. doi: 10.1186/s40662-023-00356-z. |
| 37015996 | Derived | Lam CSY, Tang WC, Zhang HY, Lee PH, Tse DYY, Qi H, Vlasak N, To CH. Long-term myopia control effect and safety in children wearing DIMS spectacle lenses for 6 years. Sci Rep. 2023 Apr 4;13(1):5475. doi: 10.1038/s41598-023-32700-7. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| cycloplegic spherical equivalent refraction (SER) | Mean | Standard Deviation | Diopters (D) |
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| Axial length | Mean | Standard Deviation | mm |
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| Participants |
|
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| Secondary | Axial Length | Axial length (mm) was measured after cycloplegia using IOL Master | completed 2-year study | Posted | Mean | Standard Deviation | mm | Baseline and 2 years |
|
|
|
| 90 |
| 0 |
| 90 |
| 0 |
| 90 |
| EG001 | MS Group | Multi-segment lens (or called DIMS lens) | 0 | 93 | 0 | 93 | 0 | 93 |
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