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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
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.
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.
University of New South Wales
Sydney, New South Wales, Australia
Axial length progression
Change in Axial Length between two eyes measured by laser interferometry (IOL Master)
Time 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.
Cycloplegic autorefraction
Change in Autorefraction between two eyes as measured by autorefractor
Time 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.
Subjective refraction
Change in subjective refraction between two eyes using phoropter or trial frame
Time 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.
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.
Time frame: 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.
Time frame: Baseline, 6-month and 12-month study visits. Added after already enrolling 9 participants.
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.