Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
NCT06753773

Red Light Therapy: Short-term Choroidal and Retinal Changes

Led by The Hong Kong Polytechnic University · Updated on 2024-12-31

60

Participants Needed

1

Research Sites

40 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Red Light Therapy: Short-term Choroidal and Retinal Changes

Who Can Participate

Age: 18Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 40 years
  • Myopic spherical equivalent refraction between -1.00D and -6.00D in both eyes
  • Best corrected visual acuity of 20/20 or better
  • Provide informed consent to participate
Not Eligible

You will not qualify if you...

  • Anisometropia greater than 1.50D
  • Eye diseases other than refractive errors, including strabismus and binocular vision abnormalities
  • Systemic diseases such as endocrine or cardiac conditions, or developmental abnormalities
  • Inability to attend regular follow-up visits
  • Received repeated low-level red-light therapy in the past 6 months
  • Contraindications to repeated low-level red-light therapy

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

M

Mingguang He

CONTACT

Y

Yanxian Chen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Red Light Therapy: Short-term Choroidal and Retinal Changes | DecenTrialz