Diabetes Mellitus, Type 2, Diabetic Retinopathy
Conditions
Keywords
Repeated low-level red-light (RLRL) therapy, Choroidal thickness
Brief 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. 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
Interventions
DEVICERLRL device
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.
Sponsors
The Second People's Hospital of Foshan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 35-55 years 2. Diagnosis of type 2 diabetes mellitus 3. No DR or only mild non-proliferative DR (NPDR) assessed by baseline clinical ocular signs and 7-field fundus color photography
Exclusion criteria
1. Spherical equivalent (SE) ≤ -6.0 diopter or axial length ≥26 mm 2. Patients with complications such as DME and retinal detachment 3. History of ocular surgical operations 4. Severe systemic diseases 5. Those who could not cooperate with the examination for any reason 6. Cognitive impairment or mental illness 7. Patients with other ocular diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in subfoveal choroidal thickness | 1 month | Changes in subfoveal choroidal thickness after 1-month RLRL treatment, which is measured by optical coherence tomography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in choroidal vascularity index | 1 month | Changes in choroidal vascularity index after 1-month RLRL treatment, which is measured by optical coherence tomography. |
| Changes in OCTA-derived parameters of the choroid and retina | 1 month | Changes in OCTA-derived parameters of the choroid and retina after 1-month RLRL treatment |
| Changes in DR grading | 1 month | Changes in DR grading after 1-month RLRL treatment |
Contacts
Primary ContactXiangbin Kong, PhD
Backup ContactCong Li, MD
Outcome results
None listed