MALCOLM - MultifocAL COntact Lenses for Myopia

Not Applicable

Recruiting

• Conditions: Myopia; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12620000159954
• Lead Sponsor: SW Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-13
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified