Choroidal and Retinal Changes After RLRL Therapy in Diabetes and Diabetic Retinopathy

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effect of Repeated Low-level Red-light (RLRL) Therapy on the Choroid and the Retina in Diabetes and Diabetic Retinopathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05773209
• Other study ID #: SecondPeopleFoshan
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2023
• Source: The Second People's Hospital of Foshan
• Contact: Xiangbin Kong, PhD
• Phone: +86075788032111
• Email: xiangbin_kong[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: December 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Retinopathy
• Retinal Diseases

Intervention

Device:
• RLRL 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Second People's Hospital of Foshan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in subfoveal choroidal thickness	Changes in subfoveal choroidal thickness after 1-month RLRL treatment, which is measured by optical coherence tomography.	1 month
Secondary	Changes in choroidal vascularity index	Changes in choroidal vascularity index after 1-month RLRL treatment, which is measured by optical coherence tomography.	1 month
Secondary	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	1 month
Secondary	Changes in DR grading	Changes in DR grading after 1-month RLRL treatment	1 month