Recruiting

Observational Study

Sponsor:

The University of New South Wales

Code:

NCT06119243

Conditions

Myopia

Eligibility Criteria

Sex: All

Age: 4 - 14

Healthy Volunteers: Not accepted

Interventions

Vivior

Study Details

Brief summary:

Currently, optical and pharmacological interventions have been developed to prevent the progression of childhood myopia. However, no myopia control strategy has been shown to have complete efficacy in controlling myopia progression in children. One possible reason is that risk factors contributing to the development of myopia were not controlled in previous clinical studies including time outdoors and near vision behaviour. This study aims to quantify time spent outdoors and near vision behavior in myopic children and its impact on myopia control efficacy. The outcomes of this study will guide clinicians on risk management and improve responses to existing treatments for progressive myopia.

Conditions

Myopia

Study ID

NCT06119243

Start date

Mar 21, 2023

Status verified date

Dec, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 14

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Aged 6 to below 14 years old
2. Spherical equivalent myopic refractive error greater than -0.50 D
3. Best corrected logMAR visual acuity of 0.1 or better in each eye for 6- to 14-year-old children, and 0.2 logMAR or better than in each eye for 4 and 5-year-old children (adjusted for age-related expectations)
4. Good ocular and general health that would not preclude them from myopia control
5. Competent enough in English to fully understand the participant information and consent form
6. Willing to undergo treatment to slow myopia progression for one year

Exclusion Criteria:

1. Strabismus at distance or near, or amblyopia
2. Systemic or ocular conditions that may affect contact lens use (e.g. severe allergy) or refractive development (e.g. ptosis)
3. Previous history of ocular surgery, trauma or chronic ocular disease that may affect their vision
4. Ocular or systemic medication use which may interfere or interact with myopia treatment or ocular development
5. Child, parents or guardians not willing to comply with treatment and/or follow-up schedule and planning to migrate or move during the one-year study duration

Study Design

Enrollment

230 participants

Anticipated

Interventions and Outcome Measures

Interventions

Vivior

The Vivior is a wearable clip-on sensor that objectively quantifies near viewing distance and duration, and ambient illumination. The Vivior will be attached to the spectacles frame of children undergoing myopia control treatment.

Primary outcome measure

  • Near viewing duration [ Time Frame: 12 months ]
  • Near viewing distance [ Time Frame: 12 months ]
  • Outdoor time [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Pauline Kang, PhD

612 9065 6112p.kang@unsw.edu.au

Locations

New England College of Optometry

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

The University of New South Wales

Last update posted

Dec 12, 2024

Last verified

Dec, 2024

Keywords

  • Myopia
  • Myopia control
  • Progressive myopia
  • Near vision behavior
  • Outdoor activity
  • Environment
  • Light exposure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of New South Wales on 2024-12-12.