Real-world Registry Study of Red Light Treatment on Myopia Control: a Focus on Non-responders to Conventional Treatments

NCT ID: NCT06569810

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-09-01

Brief Summary

This real-world observational registry study aims to assess the effectiveness of Repeated Low-Level Red Light (RLRL) therapy in controlling myopia progression among children aged 8 to 16 who have not responded to conventional treatments like Orthokeratology and atropine eyedrops. The primary focus is to determine if RLRL therapy can limit axial length (AL) elongation to less than 0.1mm per year and spherical equivalent refraction (SER) progression to less than 0.25 diopter per year, while also evaluating safety and visual outcomes.

Conditions

Myopia; Repeated Low-level Red Light

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Non-responders to Conventional Treatments

This observational, real-world, web-based registry study will collect treatment data from multiple clinics of children aged 8-16 years old who have insufficient control of progression under myopia treatments for at least six months, and are receiving or intend to receive RLRL therapy. Insufficient control is defined as meeting either of the following criteria: AL elongation of less than 0.3mm per year or SER progression of 0.5 diopter (D) or greater per year. These subjects will then be defined as non-responders to conventional treatments for myopia, and offered RLRL therapy.

Repeated Low-Level Red Light (RLRL) therapy

Intervention Type: DEVICE

In our study, we do not implement any interventions; rather, we collect follow-up information from patients who, due to insufficient response to traditional myopia control therapies, have transitioned to Repeated Low-Level Red Light (RLRL) therapy. The data gathered will reflect treatment patterns as per the approved indications for RLRL therapy, where subjects may have undergone treatment sessions twice daily, each lasting for 3 minutes with a minimum interval of 4 hours between sessions. Our analysis will focus on the real-world outcomes, specifically evaluating the proportion of participants who have achieved effective myopia control (defined as AL elongation of less than 0.1mm per year or SER progression of less than 0.25 diopter per year) after 12 months of documented RLRL therapy use among the collected data from eligible subjects.

Interventions

Repeated Low-Level Red Light (RLRL) therapy

In our study, we do not implement any interventions; rather, we collect follow-up information from patients who, due to insufficient response to traditional myopia control therapies, have transitioned to Repeated Low-Level Red Light (RLRL) therapy. The data gathered will reflect treatment patterns as per the approved indications for RLRL therapy, where subjects may have undergone treatment sessions twice daily, each lasting for 3 minutes with a minimum interval of 4 hours between sessions. Our analysis will focus on the real-world outcomes, specifically evaluating the proportion of participants who have achieved effective myopia control (defined as AL elongation of less than 0.1mm per year or SER progression of less than 0.25 diopter per year) after 12 months of documented RLRL therapy use among the collected data from eligible subjects.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age: 8 to 16 years at the time of data collection, aligning with the approved usage guidelines of the RLRL device.

2. Diagnosed with myopia and have been under conventional myopia treatments (include Orthokeratology, defocus incorporated multiple segments spectacles or equivalent, and 0.01% atropine or 0.05% atropine eyedrops) for at least six months. Eligible patient data must demonstrate insufficient control of myopia progression, defined as an axial elongation of 0.3 mm or more, or SER progression of 0.5 diopter or greater per year.

3. Best corrected visual acuity (BCVA): 20/20 or greater.

4. Data from patients who have utilized or are utilizing red light therapy as part of their myopia management strategy.

Exclusion Criteria

1. Ophthalmic diseases other than refractive errors, including but not limited to strabismus and binocular vision abnormalities in either eye.

2. Presence of systemic diseases (e.g., endocrine, cardiac diseases) and developmental abnormalities.

3. Concurrent use of atropine eye drops and RLRL therapy.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

MIngguang He, PhD

Role: CONTACT

mingguang.he@polyu.edu.hk

85234002795

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

HSEARS20240113001

Identifier Type: -

Identifier Source: org_study_id