Cataract with Dry Eye
Conditions
Interventions
Cyclosporin A Group:Use Cyclosporine A + Hyaluronic Acid.
Hyaluronic Acid Group:Use Hyaluronic Acid.
Sponsors
Changzhou Third People's Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Aged 50- 90; 2.Diagnosed with age - related cataract, meeting the indications for phacoemulsification + intraocular lens (IOL) implantation and scheduled for the surgery; 3.Pre - operatively diagnosed with moderate dry eye, meeting any of the diagnostic criteria for moderate dry eye listed in the "Chinese Expert Consensus on Dry Eye: Diagnosis (2020)"; 4.Having signed the informed consent form and able to undergo the examinations, complete the 3 - month treatment and follow - up.
Exclusion criteria
Exclusion criteria: 1. Patients at high risk of intraoperative or postoperative complications; 2. History of ocular trauma, blepharitis, ocular infections unrelated to dry eye within 3 months prior to enrolment, or filamentary keratitis; severe dry eye, Sjögren’s syndrome, allergic conjunctivitis, active ocular surface disease, history of viral keratitis, history of corneal surgery, iritis, uveitis, history of refractive corneal surgery, pterygium, glaucoma, active retinal disease, systemic immune-related diseases, etc.; 3. Patients with incomplete eyelid closure, or those who have undergone double eyelid surgery or other eyelid plastic surgery; 4. Use of the following prior to the screening period: Systemic and topical ocular immunosuppressants and immunotherapy (e.g. cyclosporine, tacrolimus, etc.): 30 days (topical ocular use), 60 days (systemic use) Corticosteroids: 30 days Lifest eye drops: 14 days Intranasal tear nerve stimulation: 14 days Serum tears: 14 days Ophthalmic or oral non-steroidal anti-inflammatory drugs (NSAIDs): 7 days Ophthalmic or oral antihistamines or mast cell stabilisers: 7 days Ophthalmic or intranasal vasoconstrictors: 7 days Other topical ophthalmic preparations (including artificial tears): 3 days; 5. Patients with hypersensitivity to any of the medicinal products used in this study; 6. Patients with severe primary diseases of the liver, kidneys or haematopoietic system, or psychiatric disorders; 7. Patients unable to complete the 3-month follow-up; 8. Patients participating in other clinical trials or lost to follow-up during the follow-up period; 9. Patients with any other condition deemed by the investigator to preclude enrolment; 10. Subjects who have used other investigational medicinal products or devices within 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear Film Break-Up Time;Ocular Surface Disease Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Meibomian Gland Morphology Examination;Corneal Fluorescein Staining Score;Conjunctival Lissamine Green Staining;Visual Acuity (including Uncorrected Visual Acuity + Corrected Visual Acuity);Refraction Examination (including Computerized Refraction + Manifest Refraction);Ocular Redness Index;Schirmer's Test;Intraocular Pressure;Tear Meniscus Height; | — |
Countries
China
Contacts
Public ContactDeng Guohua
Changzhou Third People's Hospital
Outcome results
None listed