MedDataX Logo

Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study

NCT ID: NCT06119243

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-21

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Queensland University of Technology

OTHER

Sponsor Role collaborator

New England College of Optometry

OTHER

Sponsor Role collaborator

State University of New York College of Optometry

OTHER

Sponsor Role collaborator

University of California, Berkeley

OTHER

Sponsor Role collaborator

The University of New South Wales

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pauline Kang

Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

School of Optometry, University of California, Berkeley

Berkeley, California, United States

Site Status ACTIVE_NOT_RECRUITING

New England College of Optometry

Boston, Massachusetts, United States

Site Status RECRUITING

State University of New York (SUNY), College of Optometry

New York, New York, United States

Site Status NOT_YET_RECRUITING

School of Optometry and Vision Science, UNSW

Sydney, New South Wales, Australia

Site Status RECRUITING

Optometry and Vision Science, Queensland University of Technology

Kelvin Grove, Queensland, Australia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Australia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Pauline Kang, PhD

Role: CONTACT

Phone: 612 9065 6112

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Fuensanta Vera-Diaz, PhD

Role: primary

Xiaoying Zhu, PhD

Role: primary

Pauline Kang, PhD

Role: primary

Pauline Kang, PhD

Role: backup

Emily Pieterse, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MENOK

Identifier Type: -

Identifier Source: org_study_id