ChoroidNCT05747742
Effect of Different Intensities of Repeated Low-Level Red-Light Therapy on Choroidal and Retinal Blood Flow Among Adults
A study testing RLRL device in people with Choroid and Retina, run by The Second People's Hospital of Foshan at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- What is being tested?
- RLRL device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2023to 27 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Shiran Zhang, MD contact
China1 site, 1 recruiting
- Recruiting
The Second People's Hospital of Foshan
Foshan, Guangdong, 528000
Xiangbin Kong, MD, PhD, +86075788032111, hxgcrco@shsyf.com
About this study
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.
Read the 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.
- Being tested
- RLRL device
- Keywords
- repeated low-level red light therapy, choroid, retina, optical coherence tomography, optical coherence tomography angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RLRL deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: RLRL device |
| 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. Receives: Device: RLRL device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (3)
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
Measured: 1 month
Changes in OCTA-derived parameters of retina.
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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start3 Mar 2023
- Primary completion1 Jun 2023 (estimated)
- Study completion27 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChoroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second People's Hospital of Foshan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747742
- Sponsor's protocol ID
- (2022)-0130
- Status last verified
- Mar 2023
- First submitted
- 17 Feb 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Intensities of Repeated Low-Level Red-Light Therapy on Choroidal and Retinal Blood Flow Among Adults
- ClinicalTrials.gov ID
- NCT05747742
- Acronym / sponsor ID
- (2022)-0130
- Keywords
- repeated low-level red light therapy, choroid, retina, optical coherence tomography, optical coherence tomography angiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The Second People's Hospital of FoshanUniversity, hospital or other
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 27 Jun 2023 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RLRL of 50% intensity | Experimental | Device: RLRL deviceParticipants 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 | Device: RLRL deviceParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RLRL deviceCrossover 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. | Device | RLRL of 100% intensity, RLRL of 50% intensity |
Primary outcome
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.
3 secondary outcomes
Changes in OCTA-derived parameters of choriocapillaris.
Time frame: 1 month
Changes in OCTA-derived parameters of retina.
Time frame: 1 month
Incidence of treatment-emergent adverse events
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiran Zhang, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RLRL device in people with Choroid and Retina, run by The Second People's Hospital of Foshan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangbin Kong, MD. PhD (+86075788032111, hxgcrco@shsyf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of macular choroidal thickness. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.