Diabetes Mellitus, Type 2NCT05773209
Choroidal and Retinal Changes After RLRL Therapy in Diabetes and Diabetic Retinopathy
A study testing RLRL device in people with Diabetes Mellitus, Type 2 and Diabetic Retinopathy, run by The Second People's Hospital of Foshan.
Trial summary
The choroidal thickness was found to be thinner in diabetic eyes without retinopathy compared to healthy eyes, thus choroidal thickness might be an important parameter for the development of diabetic retinopathy in diabetic eyes without retinopathy. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetic Retinopathy
- What is being tested?
- RLRL device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2023to 30 Dec 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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 35-55 years
- Diagnosis of type 2 diabetes mellitus
- No DR or only mild non-proliferative DR (NPDR) assessed by baseline clinical ocular signs and 7-field fundus color photography
Who cannot join
- Spherical equivalent (SE) ≤ -6.0 diopter or axial length ≥26 mm
- Patients with complications such as DME and retinal detachment
- History of ocular surgical operations
- Severe systemic diseases
- Those who could not cooperate with the examination for any reason
- Cognitive impairment or mental illness
- Patients with other ocular diseases
Trial locations and contacts
No sites are listed yet.
Cong Li, MD contact
About this study
Official title: Effect of Repeated Low-level Red-light (RLRL) Therapy on the Choroid and the Retina in Diabetes and Diabetic Retinopathy
The choroidal thickness was found to be thinner in diabetic eyes without retinopathy compared to healthy eyes, thus choroidal thickness might be an important parameter for the development of diabetic retinopathy in diabetic eyes without retinopathy. 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. This study aims to answer whether RLRL therapy can thicken choroidal thickness in adults with diabetes mellitus or diabetic retinopathy.
Read the detailed description
The goal of this study is to investigate the effect of repeated low-level red-light (RLRL) therapy on the choroidal and retinal structures in diabetes mellitus and diabetic retinopathy. This study will be conducted with a prospective randomized cross-over design with a total follow-up of 3 months. The control group will use the sham device but with only 5% of the original device's power. Comprehensive ophthalmic examinations, including visual acuity, intraocular pressure, optical coherence tomography, optical coherence tomography angiography, slit lamp will be assesses at baseline and within the follow up
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Retinopathy
- Being tested
- RLRL device
- Keywords
- Repeated low-level red-light (RLRL) therapy, Choroidal thickness
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Retinopathy
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 5% 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 100% intensity | Experimental | Participants will be treated with RLRL treatment (100% intensity) twice per day with an interval of at least 4 hours, each treatment last 3 minutes. Cross over arms after one month of use and one month of washout period. Receives: Device: RLRL device |
| RLRL of 5% intensity | Sham comparator | Participants will be treated with the sham device (5% intensity) twice per day with an interval of at least 4 hours, each treatment last 3 minutes. 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 in subfoveal choroidal thickness
Changes in subfoveal choroidal thickness after 1-month RLRL treatment, which is measured by optical coherence tomography.
Measured: 1 month
Secondary outcomes (3)
Changes in choroidal vascularity index
Changes in choroidal vascularity index after 1-month RLRL treatment, which is measured by optical coherence tomography.
Measured: 1 month
Changes in OCTA-derived parameters of the choroid and retina
Changes in OCTA-derived parameters of the choroid and retina after 1-month RLRL treatment
Measured: 1 month
Changes in DR grading
Changes in DR grading after 1-month RLRL treatment
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 posted17 Mar 2023
- Study start30 Apr 2023 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second People's Hospital of Foshan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiangbin Kong, PhD, Study chair, The Second People's Hospital of Foshan, Guangdong Province,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773209
- Sponsor's protocol ID
- SecondPeopleFoshan
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not Provided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repeated Low-level Red-light (RLRL) Therapy on the Choroid and the Retina in Diabetes and Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT05773209
- Acronym / sponsor ID
- SecondPeopleFoshan
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Retinopathy
- Keywords
- Repeated low-level red-light (RLRL) therapy, Choroidal thickness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- The Second People's Hospital of FoshanUniversity, hospital or other
- Study start
- 30 Apr 2023 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 17 Mar 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 choroidal thickness was found to be thinner in diabetic eyes without retinopathy compared to healthy eyes, thus choroidal thickness might be an important parameter for the development of diabetic retinopathy in diabetic eyes without retinopathy. 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. This study aims to answer whether RLRL therapy can thicken choroidal thickness in adults with diabetes mellitus or diabetic retinopathy.
Detailed description
The goal of this study is to investigate the effect of repeated low-level red-light (RLRL) therapy on the choroidal and retinal structures in diabetes mellitus and diabetic retinopathy. This study will be conducted with a prospective randomized cross-over design with a total follow-up of 3 months. The control group will use the sham device but with only 5% of the original device's power. Comprehensive ophthalmic examinations, including visual acuity, intraocular pressure, optical coherence tomography, optical coherence tomography angiography, slit lamp will be assesses at baseline and within the follow up
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 100% intensity | Experimental | Device: RLRL deviceParticipants will be treated with RLRL treatment (100% intensity) twice per day with an interval of at least 4 hours, each treatment last 3 minutes. Cross over arms after one month of use and one month of washout period. |
| RLRL of 5% intensity | Sham comparator | Device: RLRL deviceParticipants will be treated with the sham device (5% intensity) twice per day with an interval of at least 4 hours, each treatment last 3 minutes. Cross over arms after one month of use and one month of washout period. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 35-55 years
- Diagnosis of type 2 diabetes mellitus
- No DR or only mild non-proliferative DR (NPDR) assessed by baseline clinical ocular signs and 7-field fundus color photography
Key exclusion criteria (7 listed)
- Spherical equivalent (SE) ≤ -6.0 diopter or axial length ≥26 mm
- Patients with complications such as DME and retinal detachment
- History of ocular surgical operations
- Severe systemic diseases
- Those who could not cooperate with the examination for any reason
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 5% 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 5% intensity |
Primary outcome
Changes in subfoveal choroidal thickness
Time frame: 1 month
Changes in subfoveal choroidal thickness after 1-month RLRL treatment, which is measured by optical coherence tomography.
3 secondary outcomes
Changes in choroidal vascularity index
Time frame: 1 month
Changes in OCTA-derived parameters of the choroid and retina
Time frame: 1 month
Changes in DR grading
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 18 Apr 2023.
- Individual participant dataSharing planned: No. Not Provided
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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.
Cong Li, MD contact
Xiangbin Kong, PhD study chair
The Second People's Hospital of Foshan, Guangdong Province,China
Questions about this trial
What is this clinical trial studying?
A study testing RLRL device in people with Diabetes Mellitus, Type 2 and Diabetic Retinopathy, run by The Second People's Hospital of Foshan.
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 3 inclusion and 7 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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, PhD (+86075788032111, xiangbin_kong@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in subfoveal 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 18 Apr 2023.