Red Light Therapy: Short-term Choroidal and Retinal Changes

NCT06753773 | Recruiting DMC

• 1 other identifier: HSEARS20240715002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This research project is a prospective, randomized controlled trial designed to assess the short-term effects of varied red light therapies on the choroidal and retinal structures in adult myopes. The primary objective is to determine which specific retinal regions or cells are primarily affected by short-term repeated low-level red-light (RLRL) therapy, potentially inducing choroidal thickening. The secondary objective is to assess the safety of different types of red light therapy in adult myopes. The study will enroll 45 myopic adults aged 18-40 years old as participates. They will be randomly assigned into three RLRL groups: small circle (d=0.30mm), medium circle (d=0.50mm), and annular groups (an inner diameter of 0.50 mm and an outer diameter of 0.70mm) without disclosure of their specific group to maintain study blinding. The groups are differentiated by the size and shape of the light spots formed on the retina but with the same power (0.15 mW with a 4 mm pupil size). The Eyerising Myopia Management Device, modified for this study, will be used to administer RLRL with three different spot patterns, adhering to safety standards to minimize risk and ensure participant safety. Before the treatment, baseline data will be collected from each participant. Baseline assessments will consist of demographics information, visual acuity checks, axial length measurements, subjective refraction, slit-lamp examinations, adaptive optics imaging, optical coherence tomography and angiography (OCT \& OCTA), posterior blood flowgraphy, electroretinography (ERG), and the Flicker-plus test. Then participants will undergo daily treatments for 14 days, using the therapy settings of the group to which they have been assigned. The treatment will last for 3 minutes twice a day, with a minimal interval of 4 hours. During the 14-day study period, participants will undergo daily assessments by a series of ophthalmic examinations. Outcomes measured will track changes in choroidal thickness, electrical activity of the retina, axial length, and best corrected visual acuity, alongside other image reports such as adaptive optics imaging, posterior blood flowgraphy and OCT \& OCTA scans. This study addresses the gaps in understanding how RLRL therapy affects myopia and aims to identify the retina's high-response areas to red light. By doing so, it hopes to minimize unnecessary exposure and potential damage, enhancing the safety and effectiveness of the therapy.

Conditions

Myopia

Keywords

myopia; red light therapy; choroidal; retinal

Outcome Measures

Primary Outcomes (1)

• Change in choroidal thickness measured by OCT

  The change in choroidal thickness (ChT) after 14-day of repeated low-level red-light therapy in adult myopes. OCT and OCTA imaging will be performed using the ultra-wide field swept-source OCT/A system (VG200). The macula was scanned using the 12-line radial scan pattern with a resolution of 1024 × 12. Each image will cover an area of 12 × 9 mm centered on the fovea with an average of 4 consecutive scan overlaps. ChT is defined as the perpendicular distance between the outer choroid-sclera margin and the retinal pigment epithelium-Bruch's complex. The average ChT of the whole ETDRS 9 grid and central ChT (an area centered on the fovea with a diameter of 1 mm) was calculated with the built-in software. The VG200 device has been acquired by our team and is available for use.

  Choroidal thickness will be measured every day from enrollment to the end of treatment at 2 weeks.

Secondary Outcomes (7)

• Change in electrical activity of the retina measured by ERG

  ERG will be carried out on the 7th and 14th days of the study

• Change in axial length (AL) measured by IOL Master

  AL will be taken every day from enrollment to the end of treatment at 2 weeks.

• Change in best corrected visual acuity (BCVA)

  BCVA will be taken every day from enrollment to the end of treatment at 2 weeks.

• Change in adaptive optics imaging

  Adaptive optics imaging assessment will be carried out on the 7th and 14th days of the study.

• Change in optical coherence tomography angiography (OCTA) scan

  OCTA assessment will be taken every day from enrollment to the end of treatment at 2 weeks.

Study Arms (2)

Standard group

ACTIVE COMPARATOR

15 subjects will be recruited in the Standard group, where participants will use the current standard Repeated Low-Level Red-Light device.

Device: Repeated Low-Level Red-Light

Other types of red light therapy group

EXPERIMENTAL

These 45 subjects will be randomly assigned into three groups: small circle, medium circle, and annular red light groups without disclosure of their specific group to maintain study blinding.

Device: Repeated Low-Level Red-Light

Interventions

Repeated Low-Level Red-Light DEVICE

All participants will receive a video guide of the Repeated Low-Level Red-Light device. Eligible subjects will receive daily treatment for 14 days, with each treatment lasting for 3 minutes twice a day, with a minimal interval of 4 hours.

Other types of red light therapy group; Standard group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 to 40 years.
• Myopic spherical equivalent refraction (SER) between -1.00D to -6.00D in both eyes.
• Best corrected visual acuity (BCVA): 20/20 or greater.
• Informed consent for participation.

You may not qualify if:

• Anisometropia greater than 1.50D.
• Ophthalmic diseases other than refractive errors, including but not limited to strabismus and binocular vision abnormalities in either eye.
• Systemic diseases (e.g., endocrine, cardiac diseases) and developmental abnormalities.
• Inability to attend regular follow up assessment.
• Undergo RLRL therapy in the past 6 months
• Contraindications to RLRL therapy.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Mingguang He

CONTACT

85234002795; mingguang.he@polyu.edu.hk

Yanxian Chen

CONTACT

85227666111; yan-xian.chen@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: December 31, 2024
• Study Start: December 22, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)