Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RLRL of 50% intensity | Experimental | 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. |
|
| RLRL of 100% intensity | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RLRL device | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in OCTA-derived parameters of choriocapillaris. | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangbin Kong, MD. PhD | Contact | +86075788032111 | hxgcrco@shsyf.com | |
| Shiran Zhang, MD | Contact | shawn_zhangsr@hotmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second People's Hospital of Foshan | Recruiting | Foshan | Guangdong | 528000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Incidence of treatment-emergent adverse events | 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 |