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MALCOLM - MultifocAL COntact Lenses for Myopia

MALCOLM - MultifocAL COntact Lenses for Myopia and their effect on axial length elongation in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000159954
Acronym
MALCOLM
Enrollment
63
Registered
2020-02-13
Start date
2021-02-25
Completion date
2024-11-13
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

ACUVUE OASYS for PRESBYOPIA contact lenses prescribed by a registered optometrist to children with myopia will be worn in one eye for 10 hours a day for one year. These lenses will be provided to participants by the study. The lens power will be determined at the discretion of the optometrist. These lenses will be in different packaging than lenses for the other eye.

Sponsors

UNSW Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026