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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.05% cyclosporine eyedrops combined with artificial tear eyedrops | Experimental |
| |
| artificial tear eyedrops | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| artificial tear eyedrops | Drug | The intervention group and control group were treated with artificial tear eyedrops four times a day. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | from baseline to 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from baseline to 3 months after treatment |
| the concentration of Interleukin-1β (IL-1β) (pg/ml) |
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Inclusion Criteria:
I. Age: 50 to 70 years old; II. Gender: No restriction; III. Meets the diagnostic criteria for dry eye: Refer to the 2020 Chinese Expert Consensus on Diagnostic Criteria for Dry Eye.
IV. Meets the diagnostic criteria for diabetes: History of type 2 diabetes with a course of ≥5 years; Diagnosis refers to the 1999 WHO Diagnostic Criteria for Diabetes.
V. Provision of written informed consent.
Exclusion Criteria:
I. active ocular infection, ocular inflammation, active ocular allergy, severe blepharitis or obvious inflammation of the eyelid margin.
II. Uncontrolled systemic disease. III.Suffer from diseases that may affect corneal nerves, such as keratoconus, trigeminal neuralgia, allergic conjunctivitis, etc.
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| Name | Affiliation | Role |
|---|---|---|
| Hong Qi | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| 0.05% cyclosporine eyedrops | Drug | The intervention group was treated twice a day. |
|
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. |
| 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. | 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. | 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. | from baseline to 3 months after treatment |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |