Effect of Different Wavelengths of Repeated Low-Level Light Therapy on Choroidal and Retinal Blood Flow Among Adults

NCT05796856 | Unknown

• 1 other identifier: (2022)-0140
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Choroid; Retina

Outcome Measures

Primary Outcomes (1)

• 1. Changes of macular choroidal thickness

  Changes in the macular choroidal thickness are characterized as the difference following 1 month with RLRL therapy relative to the baseline which is measured by optical coherence tomography

  1 month

Secondary Outcomes (3)

• Changes in OCTA-derived parameters of choriocapillaris

  1 month

• Changes in OCTA-derived parameters of retina

  1 month

• Incidence of treatment-emergent adverse events

  1 month

Study Arms (2)

Repeated low-level light therapy (wavelength: 810 nm)

EXPERIMENTAL

Participants will be treated with repeated low level light therapy (wavelength of 650 nm) twice per weekday with an interval of at least 4 hours, each treatment last 3 minutes. Single-vision spectacles with power for correcting distance refraction will also be used if necessary.

Device: repeated low level light device (Eyerising [Suzhou Xuanjia Optoelectronics Technology)

Repeated low-level light therapy (wavelength: 650 nm)

ACTIVE COMPARATOR

Participants will be treated with repeated low level light therapy (wavelength of 650 nm) twice per weekday with an interval of at least 4 hours, each treatment last 3 minutes. Single-vision spectacles with power for correcting distance refraction will also be used if necessary.

Device: repeated low level light device (Eyerising [Suzhou Xuanjia Optoelectronics Technology)

Interventions

repeated low level light device (Eyerising [Suzhou Xuanjia Optoelectronics Technology) DEVICE

crossover device (repeated low level light device with wavelength of 810/650 nm- alternate to first group) Cross over arms after one month of use and one month of washout period.

Repeated low-level light therapy (wavelength: 650 nm); Repeated low-level light therapy (wavelength: 810 nm)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-40 years at enrolment.
• Healthy adults with best corrected visual acuity equal to or better than 1.0 in both eyes.
• Provision of consent and able to participate in all required activities of the study.

You may not qualify if:

• 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; or high myopia \< -8 diopters.
• Strabismus and vision abnormalities (astigmatism \> 3.5 D) in either eye.
• Refractive media opacity: corneal opacities, cataracts, or implanted intraocular lens, etc.
• Ocular abnormalities that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma, or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.
• Previous history of refractive surgery, intraocular surgery, laser therapy, and intravitreal injection, etc.
• Systemic abnormalities: diabetes, hypertension, etc.
• Drugs therapies with toxicity effects on the retina: hydroxychloroquine, etc.
• Prior treatment of myopia control in the past three months including drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc.
• Other contraindications, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.

Sponsors & Collaborators

• The Second People's Hospital of Foshan: lead

Central Study Contacts

Xiangbin Kong, MD. PhD

CONTACT

+862153555032; hxgcrco@shsyf.com

Shiran Zhang, MD

CONTACT

shawn_zhangsr@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 4, 2023
• Study Start: April 8, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 15, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share