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Evaluation of the exosome effect of Wharton jelly mesenchymal stem cells in the treatment of dry eye

Phase 1
Recruiting
Conditions
Dry eye due to Sjogren's syndrome.
Sicca syndrome [Sjogren]
M35.0
Registration Number
IRCT20211102052948N1
Lead Sponsor
Shiraz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
5
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

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.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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