Clinical trial NCT05747742: Effect of Different Intensities of Repeated Low-Level Red-Light Therapy on Choroidal and Retinal Blood Flow Among Adults
Official title: Effect of Different Intensities of Repeated Low-Level Red-Light Therapy on Choroidal and Retinal Blood Flow Among Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Choroid
Retina
Keywords: repeated low-level red light therapy
choroid
retina
optical coherence tomography
optical coherence tomography angiography
Lead sponsor: The Second People's Hospital of Foshan
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to evaluate the effect of different intensities of repeated low-level red-light (RLRL) therapy on the choroidal and retinal blood flow among adults.

Detailed description: Repeated low-level red-light (RLRL) therapy is an emerging innovative and non-invasive treatment for a variety of eye diseases. Notably, RLRL was found to be effective in thickening choroidal thickness in a 1-year randomized controlled trial, indicating its potential in modulating blood flow in the fundus. However, it remains unclear how long it takes for the RLRL to make a difference in fundus blood flow and whether there is a dose-response.

The purpose of this study is to evaluate the different intensities of RLRL on the choroidal and retinal blood flow among adults. This study will be conducted with a randomized cross-over design with a total follow-up of 3 months. The RLRL therapy will be carried out in the study site under supervision according to a standard protocol. Ophthalmic examinations, including visual acuity, intraocular pressure, optical coherence tomography, optical coherence tomography angiography, spherical equivalent refraction, slit lamp, and biometrics will be evaluated at enrollment and during follow-ups.

Eligibility criteria: Inclusion Criteria:

1. Aged 18-40 years at enrolment.
2. Healthy adults with best corrected visual acuity equal to or better than 1.0 in both eyes.
3. No other ocular condition except for myopia.
4. Provision of consent and able to participate in all required activities of the study.

Exclusion Criteria:

1. Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome.
2. Strabismus and vision abnormalities in either eye.
3. Refractive media opacity: corneal opacities, cataracts, or implanted intraocular lens, etc.
4. Ocular abnormalities that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma, or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.
5. Previous history of refractive surgery, intraocular surgery, laser therapy, and intravitreal injection, etc.
6. Systemic abnormalities: diabetes, hypertension, etc.
7. Drugs therapies with toxicity effects on the retina: hydroxychloroquine, etc.
8. Other contraindications, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.

Primary outcomes:
measure: Changes of macular choroidal thickness.
timeFrame: 1 month
Secondary outcomes:
measure: Changes in OCTA-derived parameters of choriocapillaris.
timeFrame: 1 month
measure: Changes in OCTA-derived parameters of retina.
timeFrame: 1 month
measure: Incidence of treatment-emergent adverse events
timeFrame: 1 month
Other outcomes:
Locations:
city: Foshan
country: China
facility: The Second People's Hospital of Foshan
state: Guangdong
Study officials:
References: