Subjects
DM, diabetes mellitus, systemic disease, dry eye disease, diabetes, Diabetic, Dry Eye,, T2DM, trauma
SYSTEMIC DISEASE, HAND INFECTION, EYE INFLAMMATION, DRY EYE, AUTOIMMUNE DISEASE, DIABETES
This cross-sectional study is part of the clinical trial: the Research for the Morphology, Function and Lipids of Meibomian Glands in Diabetic Patients with Dry Eye, conducted in Department of Ophthalmology at Yangpu Hospital of Shanghai from December 2018 to December 2019. The protocol was registered in the Chinese Clinical Trial Registry (09/12/2018, ChiCTR-180001939) and approved by the medical ethics committee of the Yangpu Hospital, Tongji University School of Medicine (Shanghai, China) in accordance with the WMA Declaration of Helsinki. Written informed consent was obtained from each participant at the examination site. The eligible criteria and grouping process were reported in the previous paper [The inclusion criteria were as follows: 1) patient was at least 40 years old; 2) all assessments that qualify in the right eye to minimize the influence factors to the results; 3) any patient with T2DM fulfilled the criteria established by the WHO in 1999, with diabetes duration of at least five years for early diabetes has no or mild systemic effects; 4) any patient with DED met the criteria set out by the DEWS II in 2017; and 5) patient had a willingness to comply with the study protocol. The patients with following conditions were excluded from the study: 1) active eye inflammation and infection within the past three months; 2) use of any eye drops including artificial tears within the past three months; 3) wearing contact lenses within the past three months; 4) ocular laser surgery or other surgery and ocular trauma within the past three months; 5) other systemic disease conditions that cause dry eye, particularly autoimmune disease. A minimum sample of 24 patients per group was calculated by PASS software (a two-sided Flow chart illustration of the study procedure (DM, diabetes mellitus; DED, dry eye disease)