Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06887920

Comparison of MiSight 1-Day and Acuvue Oasys for Presbyopia in Myopic Children

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Myopia Progressing

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New South Wales

Sydney, New South Wales, 2052, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

  2. 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

  1. Subjective refraction

    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 subjective refraction between two eyes using phoropter or trial frame

  2. Estimates of outdoor time and near work

    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.

    Estimates of time spent outdoors and on near work with study specific questionnaire. Duration will be reported in minutes or hours.

  3. Quality of Life (PREP2)

    Time frame: Baseline, 6-month and 12-month study visits. Added after already enrolling 9 participants.

    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.

  4. Quality of Life (PedEyeQ)

    Time frame: Baseline, 6-month and 12-month study visits. Added after already enrolling 9 participants.

    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.

  5. Treatment adherence (Questions)

    Time frame: 1-month, 6-month and 12-month study visits. Added to initial protocol prior to enrolment commencement.

    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.

  6. Treatment adherence (Text-message surveys)

    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.

    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.

Other outcomes

  1. Corneal topography

    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 Corneal topography measurements between two eyes as measured by corneal topographer (Oculus Keratograph, Medmont E300)

  2. Amplitude of Accommodation

    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 amplitude of accommodation between the two eyes with push up test

  3. Visual acuity

    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 distance and near vision between the two eyes using visual acuity charts

  4. Anterior Chamber Depth

    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 anterior chamber depth between the two eyes with laser interferometry (IOL Master) and optical coherence tomography (Casia SS-1000)

  5. Corneal radii

    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 corneal radii between the two eyes with laser interferometry (IOL Master).

  6. Lens thickness

    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 lens thickness between the two eyes with laser interferometry (IOL Master).

  7. Posterior segment depth

    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 posterior segment depth measurements with optical coherence tomography

  8. Pupils

    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 pupillary measurements as measured by pupillometer

Sponsors and collaborators

Lead sponsor

Pauline Kang

Other

Collaborators

  • Johnson & Johnson Vision Care, Inc.

Registry information

Official study title

MultifocAL COntact Lenses for Myopia and Their Effect on Axial Length Elongation in Children

Acronym: MALCOLM

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.