Rationale, Design, Methodology and Baseline Data of Fushun Diabetic Retinopathy Cohort Study (FS-DIRECT)

ABSTRACT

Purpose: To describe the rationale, design, methodology and baseline characteristics of Fushun Diabetic Retinopathy Cohort Study (FS-DIRECT), a community-based prospective cohort study in patients with type 2 diabetes mellitus (T2DM) living in northeast China.

Methods: Patients with T2DM, aged 30 years and above from communities of Fushun city, Liaoning province, China, were recruited. The presence and severity of the diabetic retinopathy (DR) were determined by a modified Early Treatment Diabetic Retinopathy Study (ETDRS) retinopathy scale of 6 fields fundus photographs. Detailed ocular examinations and questionnaires were collated, in addition to blood and urine sample collection.

Results: Of the 2224 subjects eligible for the FS-DIRECT, 2033 (91.4%) participated in the study. The majority of participants were female (58.9%), the average age was 62.1 ± 9.1 years. The overall prevalence rates of DR, non-proliferative DR, proliferative DR, diabetic macular edema, and vision-threatening retinopathy were 44.3%, 40.0%, 4.3%, 15.2%, and 12.3%, respectively. Compared to the patients without DR, patients with DR had lower income, an earlier onset of diabetes, a longer duration of diabetes, higher proportion of insulin use, higher fasting plasma glucose, HbA1c, systolic blood pressure, total cholesterol and high density lipoprotein, as well as a higher level of urine protein (all P < .05).

Conclusion: The baseline data of FS-DIRECT showed a high prevalence of DR in a community of northeast China. Further investigation will provide key information about the risk factors, impact, and trends of DR in this region.

KEYWORDS:

• diabetes mellitus
• diabetic retinopathy
• risk factors
• community-based study
• cohort study

Acknowledgments

The authors thank Dr Jing Jiang, Yu Dou (Fushun Eye Hospital) for their invaluable assistance in data collection.

Declaration of interest

The authors declare that there are no conflicts of interest. This manuscript has not been published anywhere previously, and it is not simultaneously being considered for any other publication.

Additional information

Funding

The study was supported by Wenzhou Basic Medical and Health Technology Project (Y20190632), Liaoning Provincial Natural Science Foundation of China (20170540328), and Zhejiang Provincial Natural Science Foundation of China (LQ18H120004).