Dry eye due to Sjogren's syndrome. Sicca syndrome [Sjogren]
Conditions
Interventions
Intervention 1: Intervention group: Wharton jelly mesenchymal stem cell-derived exosomes. Participants will receive artificial tears for 2 weeks to return to normal, then WJMSC-exo 10ug / drop, four t
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
35 Years to 45 Years
Inclusion criteria
Inclusion criteria: Middle-aged women between the ages of 45 and 35 with dry eye Clinically and serologically diagnosed by an ophthalmologist, rheumatologist or internal medicine specialist with sjogren’s syndrome. Previous use of artificial tears can not relieve it. Symptoms of dry eye in at least one patient's eye include redness, dryness, burning sensation, foreign body sensation, eye discomfort, or visual fatigue. Tear discharge test (Schermer test) both eyes = 10 mm / 5 min Tear break time (TBUT) will be less than 10 seconds.
Exclusion criteria
Exclusion criteria: People who are allergic to any drug . Pregnant or lactating women . Patients with active fungal, bacterial or viral keratitis or conjunctivitis. People with serious heart, lung, liver or kidney disease or other incurable eye diseases such as glaucoma, uveitis. People who wear contact lenses and do not want to remove them in the study. Perform eye surgery (including cataract surgery) in the last three months. Simultaneous enrollment in other interventional clinical trials. Use of eye drops in the last 24 hours that may affect the clinical study. They have serious systemic diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular Surface Disease Index (OSDI) Score. Timepoint: Before the intervention and in the Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks after the intervention. Method of measurement: A valid questionnaire is 12 questions that will be used to measure the symptoms of dry eye. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in tear secretion amount. Timepoint: Before the intervention and in the time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks after the intervention. Method of measurement: Schirmer's Test.;Changes in Tear break time. Timepoint: Before the intervention and in the time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks after the intervention. Method of measurement: The time required for dry spots to appear on the surface of the eye after blinking will be measured in seconds.;Changes in Ocular Surface Staining. Timepoint: Before the intervention and in the time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks after the intervention. Method of measurement: Damage to the surface of the eye will be assessed using non-toxic eye dye during the slit lamp examination.;Changes in conjunctiva redness score. Timepoint: Before the intervention and in the time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks after the intervention. Method of measurement: Conjunctival hyperemia will be graded separately in each eye by the researcher assigning a score of 0 to 4 per quarter.;Changes in tear meniscus thickness. Timepoint: Before the intervention and in the time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks after the intervention. Method of measurement: The distance between the line of reflection along the top of the tear prism to the edge of the eyelid will be measured in millimeters.;Evaluation of MMP9, EGF gene expression in tear secretions. Timepoint: Before the intervention and in the time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks after the intervention. Method of measurement: RT-PCR technique.;Evaluation of MMP9 and EGF proteins in tear secretions. Timepoint: Before the intervention and in the time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks after the | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAzam Habibi
Shiraz University of Medical Sciences
Outcome results
None listed