MultifocAL COntact Lenses for Myopia and Their Effect on Axial Length Elongation in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Axial length progression
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 6-12 years (inclusive)
- •Is willing to wear soft contact lenses daily
- •Spherical equivalent myopic refractive error between -0.50 to -5.00 D in each eye and astigmatism < 1.00 D
- •Best corrected logMAR visual acuity of 0.1 or better in both eyes
- •Good ocular and general health
- •No previous use of myopia control interventions for more than 1 month or within the last 30 days
- •Competent enough in English to be able to fully understand the participant information and consent form
Exclusion Criteria
- •Strabismus at distance or near, amblyopia or significant anisometropia (>1D)
- •Systemic or ocular conditions that may affect contact lens use (e.g., allergy) or that may affect refractive development (e.g., ptosis)
- •Previous history of ocular surgery, trauma, or chronic ocular disease
- •Contraindications to contact lens use
- •Ocular or systemic medication use which may interfere or interact with contact lens wear or ocular development
- •Plans to migrate or move during the study
- •Child, parents or guardians not willing to comply with treatment and/or follow-up schedule
Arms & Interventions
Acuvue Oasys for Presbyopia in the RIGHT eye
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
Intervention: Acuvue Oasys for Presbyopia (Device)
MiSight 1-Day in the RIGHT eye
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
Intervention: MiSight 1 Day (Device)
Outcomes
Primary Outcomes
Axial length progression
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.
Change in Axial Length between two eyes measured by laser interferometry (IOL Master)
Cycloplegic autorefraction
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.
Change in Autorefraction between two eyes as measured by autorefractor
Secondary Outcomes
- Subjective refraction(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(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)(Baseline, 6-month and 12-month study visits. Added after already enrolling 9 participants.)
- Quality of Life (PedEyeQ)(Baseline, 6-month and 12-month study visits. Added after already enrolling 9 participants.)
- Treatment adherence (Questions)(1-month, 6-month and 12-month study visits. Added to initial protocol prior to enrolment commencement.)
- Treatment adherence (Text-message surveys)(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.)
Investigators
Pauline Kang
Associate Professor
The University of New South Wales