NCT06753773

Red Light Therapy: Short-term Choroidal and Retinal Changes

Recruiting now NA Last updated 31 December 2024

What this trial tests

NA trial testing Repeated Low-Level Red-Light in Myopia in 60 participants. Currently enrolling.

Timeline

22 December 2024

Primary endpoint
30 September 2025

30 September 2025

Quick facts

Lead sponsor	The Hong Kong Polytechnic University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	60
Start date	22 December 2024
Primary completion	30 September 2025
Estimated completion	30 September 2025
Sites	1 location across Hong Kong

Drugs / interventions tested

• Repeated Low-Level Red-Light

Conditions studied

• Myopia — all drugs for Myopia →

Sponsor

The Hong Kong Polytechnic University

Who can join

Adults 18 to 40, any sex, with Myopia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.