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

Not Applicable

Not yet recruiting

• Conditions: Diabetic Retinopathy; Diabetes Mellitus, Type 2
• Interventions: Device: RLRL device

• Registration Number: NCT05773209
• Lead Sponsor: The Second People's Hospital of Foshan

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

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-17
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18
• Study Start: 2023-04-30
• Primary Completion: 2023-10-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RLRL of 5% intensity	RLRL device	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.
RLRL of 100% intensity	RLRL device	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 DR grading	1 month	Changes in DR grading after 1-month RLRL treatment
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