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.