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| Name | Class |
|---|---|
| Johnson & Johnson Vision Care, Inc. | INDUSTRY |
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This study will compare the effects on myopia progression over the course of one year for eyes wearing MiSight 1 Day contact lenses compared to ACUVUE OASYS for PRESBYOPIA contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acuvue Oasys for Presbyopia in the RIGHT eye | Other | Acuvue Oasys for Presbyopia in the RIGHT eye and MiSight 1-Day contact lens in the LEFT eye RIGHT eye has intervention, LEFT eye has active comparator |
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| MiSight 1-Day in the RIGHT eye | Other | MiSight 1-Day contact lens in the RIGHT eye and Acuvue Oasys for Presbyopia in the LEFT eye RIGHT eye has active comparator, LEFT eye has intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acuvue Oasys for Presbyopia | Device | ACUVUE OASYS for PRESBYOPIA contact lenses will be prescribed to children with myopia to be worn in one eye for 10 hours a day for one year. |
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| Measure | Description | Time Frame |
|---|---|---|
| Axial length progression | Change in Axial Length between two eyes measured by laser interferometry (IOL Master) | 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants. |
| Cycloplegic autorefraction | Change in Autorefraction between two eyes as measured by autorefractor | 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective refraction | Change in subjective refraction between two eyes using phoropter or trial frame | 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal topography | Change in Corneal topography measurements between two eyes as measured by corneal topographer (Oculus Keratograph, Medmont E300) | 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New South Wales | Sydney | New South Wales | 2052 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40228855 | Derived | Dang R, Hui A, Jalbert I, Kho D, Vi M, Briggs N, Kang P. MultifocAL COntact Lenses for Myopia (MALCOLM) control in Australian children: a study protocol for a double-blind, contralateral eye, non-inferiority, randomised controlled clinical trial. BMJ Open. 2025 Apr 14;15(4):e086173. doi: 10.1136/bmjopen-2024-086173. |
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Non-inferiority, contralateral eye, randomised controlled trial
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| MiSight 1 Day | Device | MiSight 1 Day contact lenses will be prescribed to children with myopia to be worn in one eye for 10 hours a day for one year. |
|
| Estimates of outdoor time and near work |
Estimates of time spent outdoors and on near work with study specific questionnaire. Duration will be reported in minutes or hours. |
| 1-month, 6-month and 12-month study visits. Also 3-month and 9-month telehealth visits. 3-month visit was changed to telehealth and 9-month visit added after already enrolling 9 participants. |
| Quality of Life (PREP2) | Quality of Life measured using the PREP2 survey. Scores are derived from a scale between 0 to 100, with higher values incating better Quality of Life. | Baseline, 6-month and 12-month study visits. Added after already enrolling 9 participants. |
| Quality of Life (PedEyeQ) | Quality of Life measured using the PedEyeQ survey. Scores are derived from a scale between 0 to 100, with higher values incating better Quality of Life. | Baseline, 6-month and 12-month study visits. Added after already enrolling 9 participants. |
| Treatment adherence (Questions) | Contact lens wear duration will be calculated from study-specific questionnaire conducted at study visits. Duration will be reported as hours per day and days per week. | 1-month, 6-month and 12-month study visits. Added to initial protocol prior to enrolment commencement. |
| Treatment adherence (Text-message surveys) | Contact lens wear duration will be calculated from study-specific questionnaire sent via text-message. Duration will be reported as hours per day and days per week. | Study month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12. 1-month, 6-month and 12-month study visits. Added to initial protocol prior to enrolment commencement. |
| Amplitude of Accommodation | Change in amplitude of accommodation between the two eyes with push up test | 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants. |
| Visual acuity | Change in distance and near vision between the two eyes using visual acuity charts | 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants. |
| Anterior Chamber Depth | Change in anterior chamber depth between the two eyes with laser interferometry (IOL Master) and optical coherence tomography (Casia SS-1000) | 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants. |
| Corneal radii | Change in corneal radii between the two eyes with laser interferometry (IOL Master). | 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants. |
| Lens thickness | Change in lens thickness between the two eyes with laser interferometry (IOL Master). | 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants. |
| Posterior segment depth | Change in posterior segment depth measurements with optical coherence tomography | 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants. |
| Pupils | Change in pupillary measurements as measured by pupillometer | 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants. |