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The goal of this observational study was to compare the wearing patterns of spectacles prescribed for myopia control in juvenile wearers.
This unmasked, multi-center, observational study evaluated the wearing patterns of established (use of ≥3 months) juvenile spectacles wearers. It aimed to compare the wearing patterns of spectacles for myopia control between males and females. Wearing pattern were measured via the use of temperature sensors fitted to the sides of the participant's spectacles. Data from the final week of the 1-month study was used for analysis to minimize 'unusual' wear patterns which may have occurred early in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myopia control spectacle wearers | Established (use of ≥3 months) juvenile myopia control spectacle wearers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myopia control spectacles | Device | Myopia control spectacles fitted with temperature sensors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Wearing Pattern of Myopia Control Spectacles | Overall wearing patterns were evaluated via the use of temperature sensors fitted to the frame of the spectacles. The temperature readings from the final week of the one month study were used to determine when spectacles were worn or removed. Scores were calculated as the average times over a 24 hour period (W24) where a higher score indicated that the spectacles were worn for a longer period of time per day. | Measured continuously over 1 week of wear |
| Effect of Sex on Overall Wearing Pattern | The effect of sex on the overall wearing pattern was evaluated via the use of temperature sensors fitted to the frame of the spectacles. The temperature readings from the final week of the one month study were used to determine when spectacles were worn or removed. Scores were calculated as the average times over a 24 hour period (W24) and a 'waking day' period of 07:00 to 21:00 (W14), where a higher score indicated that the spectacles were worn for a longer period of time per day. | Measured continuously over 1 week of wear |
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Inclusion Criteria:
Exclusion Criteria:
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Juvenile participants recruited directly from the patient bases of several UK optometry practices who currently wear spectacles prescribed for myopia
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| Name | Affiliation | Role |
|---|---|---|
| Philip Morgan | Eurolens Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye2C Ltd | Sale | Cheshire | M33 7XF | United Kingdom | ||
| Susan Hilton Ltd |
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| ID | Title | Description |
|---|---|---|
| FG000 | Myopia Control Spectacles | All participants wore their habitual myopia control spectacles |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Myopia Control Spectacles | All participants of the clinical study |
| 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 | Overall Wearing Pattern of Myopia Control Spectacles | Overall wearing patterns were evaluated via the use of temperature sensors fitted to the frame of the spectacles. The temperature readings from the final week of the one month study were used to determine when spectacles were worn or removed. Scores were calculated as the average times over a 24 hour period (W24) where a higher score indicated that the spectacles were worn for a longer period of time per day. | Data for one participant was not available due to a failure of the sensors | Posted | Mean | Standard Deviation | Hours in a day | Measured continuously over 1 week of wear |
|
Duration of the study, approximately one month.
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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 | Myopia Control Spectacles | All participants of the clinical study | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| José A. Vega | CooperVision Inc. | +1 (925) 621-3761 | JVega2@coopervision.com |
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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 | Apr 17, 2024 | Oct 9, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Darwen |
| England |
| BB3 2AA |
| United Kingdom |
| Columbo Ltd | Oakwood | Leeds | LS8 2HU | United Kingdom |
| David Gould Opticians Limited | Haslingden | Rossendale | BB4 5QN | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Effect of Sex on Overall Wearing Pattern | The effect of sex on the overall wearing pattern was evaluated via the use of temperature sensors fitted to the frame of the spectacles. The temperature readings from the final week of the one month study were used to determine when spectacles were worn or removed. Scores were calculated as the average times over a 24 hour period (W24) and a 'waking day' period of 07:00 to 21:00 (W14), where a higher score indicated that the spectacles were worn for a longer period of time per day. | Posted | Least Squares Mean | 95% Confidence Interval | Hours in a day | Measured continuously over 1 week of wear |
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| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
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