The objective of this study is to observe the effects of 0.05% cyclosporine eye drops combined with artificial tears on patients with diabetes-associated dry eye, and to monitor changes in ocular surface characteristics and inflammatory cytokines in tears before and after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The intervention group and control group were treated with artificial tear eyedrops four times a day.
The intervention group was treated twice a day.
Peking University Third Hospital
Beijing, Beijing Municipality, China
ocular surface disease index (OSDI)
OSDI is one of the most frequently used questionnaires for evaluation of dry eye disease (DED). This includes 12 questions which measure the frequency of symptoms over the recent week, and the scores range from 0 to 100.
Time frame: from baseline to 3 months after treatment
Tear break-up time (TBUT)(s)
BUT is the time from normal blinking to the first appearance of a break in the tear film.
Time frame: from baseline to 3 months after treatment
Corneal fluorescein staining (CFS)
The degree of fluorescein staining of the cornea was evaluated using the National Eye Institute (NEI) scale of five corneal regions (central, superior, temporal, nasal, and inferior). The scores range from 0 to 15.
Time frame: from baseline to 3 months after treatment
Schirmer I test (SIt) (mm/5 minutes)
The Schirmer I test is performed using sterile strips without anesthesia. The strips are placed in the lateral part of the inferior fornix of the eye for 5min and the extent of tear flow down was measured in millimeters.
Time frame: from baseline to 3 months after treatment
Lissamine green staining
To grade the temporal zone, the subject looks nasally; to grade the nasal zone the subject looks temporally. The upper and lower conjunctiva can also be graded.
Time frame: from baseline to 3 months after treatment
corneal sensitivity (range, 60-0 mm)
Corneal sensitivity will be measured in the right eye only using the Cochet-Bonnet aesthesiometer and the ascending method of limits to determine the threshold of stimulus detection.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: from baseline to 3 months after treatment
the concentration of Interleukin-1β (IL-1β) (pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-1β levels will be quantified by Luminex immunoassay.
Time frame: from baseline to 3 months after treatment
the concentration of Interleukin-6 (IL-6) (pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-6 levels will be quantified by Luminex immunoassay.
Time frame: from baseline to 3 months after treatment
the concentration of Interleukin-10 (IL-10) (pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-10 levels will be quantified by Luminex immunoassay.
Time frame: from baseline to 3 months after treatment
the concentration of Interleukin-17A (IL-17A) (pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-17A levels will be quantified by Luminex immunoassay.
Time frame: from baseline to 3 months after treatment