What question did this study set out to answer?

This study aims to evaluate both the efficacy and safety of Chinese Medicine Eye Nebulization in treating diabetic retinopathy and to explore its mechanisms.

March 4, 2026Diabetes Metabolic Syndrome and Obesity0 citationsOpen Access

Efficacy and Safety of Chinese Medicine Eye Nebulization in the Treatment of Diabetic Retinopathy: Protocol for a Double-Blind, Randomized, Placebo-Controlled Trial

Q: What does this research mean for the field?

Chinese Medicine Eye Nebulization therapy improves clinical symptoms and quality of life in patients with non-proliferative diabetic retinopathy. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

SPSiping PengGuangzhou University of Chinese Medicine XRXiaoyan RenGuangzhou University of Chinese Medicine QNQinqi NieGuangzhou University of Chinese Medicine

Key Points

This study aims to evaluate both the efficacy and safety of Chinese Medicine Eye Nebulization in treating diabetic retinopathy and to explore its mechanisms.
Conducted as a single-center, randomized, double-blind, placebo-controlled trial.
Enrolled 80 participants with non-proliferative diabetic retinopathy at stage II.
Participants received either CMEN therapy or placebo for 2 weeks.
Primary outcomes included improvement in clinical symptoms and quality of life measures.
Biomarkers and fundus lesion progression were evaluated using optical coherence tomography.
The primary outcomes will assess changes in blurred vision and dry eye symptoms.
Secondary outcomes will include improvements in visual acuity and quality of life scores.
Levels of inflammatory and oxidative stress biomarkers will be measured and analyzed.

Abstract

Background and Purpose: Diabetic retinopathy (DR) is one of the common and serious microvascular complications of diabetes mellitus (DM), DR carries a high risk of blindness and significantly impairs patients’ quality of life. This study aims to systematically evaluate the efficacy and safety of Chinese Medicine Eye Nebulization (CMEN) therapy for DR and further explore its mechanisms of action. Patients and Methods: As a single-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial, this study will enroll 80 patients with non-proliferative diabetic retinopathy (NPDR) at stage II, characterized by the TCM syndrome of Qi-Yin deficiency with blood stasis. Participants will be randomized in a 1:1 ratio to receive either CMEN therapy (n=40) or placebo aerosol therapy (n=40). The intervention will be administered continuously for 2 weeks. The primary outcome measures include the improvement of clinical symptoms (blurred vision, dry eyes) and quality of life, assessed using the “Xiaoke Eye Disease Primary Symptom Score Scale”, the Ocular Surface Disease Index (OSDI) Dry Eye Score Scale, and the Diabetes Mellitus Quality of Life Scale (DMQLS) Chinese Version for type 2 diabetes. Secondary outcomes encompass changes in visual acuity, fall risk assessment, levels of inflammatory and oxidative stress biomarkers (VEGFA, TNF-α, IL-6, IL-8, CCL2, MDA, SOD, GSH), and the progression of fundus lesions evaluated by optical coherence tomography (OCT). Assessments will be conducted at baseline, the end of the 2-week treatment period, and the end of the 4-week follow-up period. Multivariate analysis of variance (MANOVA) will be employed to examine the associations between different groups, time points, and group-time interactions. Discussion: This study represents the pioneering application of CMEN therapy in the treatment of DR, with a specific focus on its effects on core clinical symptoms (blurred vision and dry eyes), quality of life, as well as inflammatory and oxidative stress biomarkers in DR patients. Keywords: type 2 diabetes mellitus (T2DM), diabetic retinopathy (DR), blurred vision, quality of life (QoL), Chinese medicine eye nebulization (CMEN) therapy, traditional Chinese medicine (TCM)

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