- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05747742
Effect of Different Intensities of Repeated Low-Level Red-Light Therapy on Choroidal and Retinal Blood Flow Among Adults
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xiangbin Kong, MD. PhD
- Phone Number: +86075788032111
- Email: hxgcrco@shsyf.com
Study Contact Backup
- Name: Shiran Zhang, MD
- Email: shawn_zhangsr@hotmail.com
Study Locations
-
-
Guangdong
-
Foshan, Guangdong, China, 528000
- Recruiting
- The Second People's Hospital of Foshan
-
Contact:
- Xiangbin Kong, MD, PhD
- Phone Number: +86075788032111
- Email: hxgcrco@shsyf.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18-40 years at enrolment.
- Healthy adults with best corrected visual acuity equal to or better than 1.0 in both eyes.
- No other ocular condition except for myopia.
- Provision of consent and able to participate in all required activities of the study.
Exclusion Criteria:
- 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.
- Strabismus and vision abnormalities 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.
- Other contraindications, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RLRL of 50% intensity
Participants will be treated with RLRL (50% intensity) 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. Cross over arms after one month of use and one month of washout period. |
Crossover device (RLRL of 50% or 100% intensity - alternate to first group).
Cross over arms after one month of use and one month of washout period.
|
Active Comparator: RLRL of 100% intensity
Participants will be treated with RLRL (100% intensity) 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. Cross over arms after one month of use and one month of washout period. |
Crossover device (RLRL of 50% or 100% intensity - alternate to first group).
Cross over arms after one month of use and one month of washout period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of macular choroidal thickness.
Time Frame: 1 month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of treatment-emergent adverse events
Time Frame: 1 month
|
Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over a specified period for subjects in the intervention arm.
Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages.
|
1 month
|
Changes in OCTA-derived parameters of choriocapillaris.
Time Frame: 1 month
|
Changes in the choriocapillaris microvasculature are characterized as the difference following 1 month with RLRL therapy relative to the baseline which is measured by optical coherence tomography angiography
|
1 month
|
Changes in OCTA-derived parameters of retina.
Time Frame: 1 month
|
Changes in retinal microvasculature are characterized as the difference following 1 month with RLRL therapy relative to the baseline which is measured by optical coherence tomography angiography.
|
1 month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- (2022)-0130
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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