Clinical trial NCT06887920: Comparison of MiSight 1-Day and Acuvue Oasys for Presbyopia in Myopic Children
Official title: MultifocAL COntact Lenses for Myopia and Their Effect on Axial Length Elongation in Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia Progressing
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson Vision Care, Inc.
First posted: 2025-03-21
Enrollment: 72
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority, contralateral eye, randomised controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Aged 6-12 years (inclusive)
2. Is willing to wear soft contact lenses daily
3. Spherical equivalent myopic refractive error between -0.50 to -5.00 D in each eye and astigmatism \< 1.00 D
4. Best corrected logMAR visual acuity of 0.1 or better in both eyes
5. Good ocular and general health
6. No previous use of myopia control interventions for more than 1 month or within the last 30 days
7. Competent enough in English to be able to fully understand the participant information and consent form

Exclusion Criteria:

1. Strabismus at distance or near, amblyopia or significant anisometropia (\>1D)
2. Systemic or ocular conditions that may affect contact lens use (e.g., allergy) or that may affect refractive development (e.g., ptosis)
3. Previous history of ocular surgery, trauma, or chronic ocular disease
4. Contraindications to contact lens use
5. Ocular or systemic medication use which may interfere or interact with contact lens wear or ocular development
6. Plans to migrate or move during the study
7. Child, parents or guardians not willing to comply with treatment and/or follow-up schedule

Primary outcomes:
measure: Axial length progression
timeFrame: 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: Cycloplegic autorefraction
timeFrame: 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.
Secondary outcomes:
measure: Subjective refraction
timeFrame: 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: Estimates of outdoor time and near work
timeFrame: 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.
measure: Quality of Life (PREP2)
timeFrame: Baseline, 6-month and 12-month study visits. Added after already enrolling 9 participants.
measure: Quality of Life (PedEyeQ)
timeFrame: Baseline, 6-month and 12-month study visits. Added after already enrolling 9 participants.
measure: Treatment adherence (Questions)
timeFrame: 1-month, 6-month and 12-month study visits. Added to initial protocol prior to enrolment commencement.
measure: Treatment adherence (Text-message surveys)
timeFrame: 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.
Other outcomes:
measure: Corneal topography
timeFrame: 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: Amplitude of Accommodation
timeFrame: 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: Visual acuity
timeFrame: 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: Anterior Chamber Depth
timeFrame: 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: Corneal radii
timeFrame: 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: Lens thickness
timeFrame: 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: Posterior segment depth
timeFrame: 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: Pupils
timeFrame: 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.
Locations:
city: Sydney
country: Australia
facility: University of New South Wales
state: New South Wales
Study officials:
References: