Myopia
Conditions
Brief summary
The goal of this observational study was to compare the wearing patterns of spectacles prescribed for myopia control in juvenile wearers.
Detailed description
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.
Interventions
Myopia control spectacles fitted with temperature sensors
Sponsors
CooperVision, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
1. They are aged between six and 15 years old. 2. Their parent or guardian understands the rights of the subject and are willing to sign a statement of informed consent. 3. They understand the study at a level appropriate for their age and are willing to sign a statement of assent. 4. They and their parents or guardians are willing and able to follow the protocol. 5. They currently use spectacle lenses for myopia control and have done so for at least three months. 6. They agree not to participate in other clinical research for the duration of this study.
Exclusion criteria
1. They have an unusual ophthalmic history, which in the opinion of the site investigator or Principal Investigator might impact on the successful conduct of the study. 2. They are amblyopic.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Wearing Pattern of Myopia Control Spectacles | Measured continuously over 1 week of wear | 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. |
| Effect of Sex on Overall Wearing Pattern | Measured continuously over 1 week of wear | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Myopia Control Spectacles All participants of the clinical study | 53 |
| Total | 53 |
Baseline characteristics
| Characteristic | Myopia Control Spectacles | — |
|---|---|---|
| Age, Continuous | 11.2 years STANDARD_DEVIATION 2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 29 Participants | — |
| Sex: Female, Male Male | 24 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 53 |
| other Total, other adverse events | 0 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
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.
Time frame: Measured continuously over 1 week of wear
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Myopia Control Spectacles | Effect of Sex on Overall Wearing Pattern | W14 | 12 Hours in a day |
| Myopia Control Spectacles | Effect of Sex on Overall Wearing Pattern | W24 | 13.9 Hours in a day |
| Male Participants | Effect of Sex on Overall Wearing Pattern | W14 | 10.4 Hours in a day |
| Male Participants | Effect of Sex on Overall Wearing Pattern | W24 | 11.5 Hours in a day |
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.
Time frame: Measured continuously over 1 week of wear
Population: Data for one participant was not available due to a failure of the sensors
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Myopia Control Spectacles | Overall Wearing Pattern of Myopia Control Spectacles | 12.8 Hours in a day | Standard Deviation 4.1 |