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IRCT20170211032503N2 IRCT 2024-02-20 Vision health research center Using exosome to treat severe dry eyes Investigating the therapeutic effect of eye drops obtained from Wharton's jelly stem cell exosomes in patients with severe dry eyes 2024-04-29 anticipated 30 Complete https://irct.ir/trial/75189 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 0 (exploratory trials) Severe dry eye. Intervention Group: A group of 30 individuals diagnosed with dry eye disease which will referred to the Vision Health Clinic will enrolled in the study. The medication consists of eye drops containing stem cell-derived exosomes, which the patient will instill into their eyes four times a day for 12 weeks.. Yes - There is a plan to make this available What will be shared: All the results obtained based on the disease improvement process along with the age and sex of the patient will be available. When: All the results obtained based on the disease improvement process along with the age and sex of the patient will be available after the completion of the three-month follow-up period. To whom: It will be available for researchers working in academic and scientific institutions Conditions: In the case of obtaining permission from experts, the relevant applicants can access the data at the designated time. Only encrypted data and no personal patient profiles will be accessible. Where to obtain: The email address along with the contact number of the respondents will be provided to the applicants How to obtain: After the completion of the three-month treatment period, after receiving an email from the applicant, the documents will be provided to the applicant. Comments:
public Hossein Aghamollaei
Unit 17, 5th floor, No. 8, Second Alley, Vali Asr Street
Tehran Iran (Islamic Republic of) 1516747418 +98 21 8819 6862 aghamolaei22@gmail.com Vision health research center scientific Khosrow Jadidi
Unit 17, 5th floor, No. 8, Second Alley, Vali Asr Street
Tehran Iran (Islamic Republic of) 1516747418 +98 21 8819 6862 kh.jadidi@gmail.com Vision health research center Iran (Islamic Republic of) People with severe dry eye based on symptoms in at least one eye: dryness, burning sensation, foreign body sensation, discomfort in the ocular surface or visual fatigue Failure to respond to routine treatments Tear secretion test (Schirmer test) both eyes ≤ 10 mm / 5 minutes. 18 years 70 years Both Those who are allergic to any of the drug components in this study. Pregnant or lactating women Patients with active fungal, bacterial or viral keratitis or conjunctivitis Suffering from serious heart, lung, liver, or kidney diseases; Patients with Diabetes H04.129 Dry eye syndrome of unspecified lacrimal gland Treatment - Drugs Intervention Group: A group of 30 individuals diagnosed with dry eye disease which will referred to the Vision Health Clinic will enrolled in the study. The medication consists of eye drops containing stem cell-derived exosomes, which the patient will instill into their eyes four times a day for 12 weeks. The percentage of patients with increasing of Tear Film Break-up Time. Timepoint: Before intervention, one week, 4 weeks and 12 weeks after intervention. Method of measurement: The time required for dry spots to appear on the surface of the eye after blinking is in seconds. A positive change from baseline indicates improvement in each eye. Ocular Surface Staining. Timepoint: Before intervention, one week, 4 weeks and 12 weeks after intervention. Method of measurement: An area of the cornea that is stained with fluorescein dye and it will be assessed using a slate lamp microscope. Ocular surface damage will be measured by slit lamp examination after staining with non-toxic sodium fluorescein. Corneal and conjunctival staining will be graded based on the National Eye Institute (NEI) imaging scale. The lower the score has the less dry eye symptoms the patient. A negative change from baseline indicates improvement in each eye. The volume of tear. Timepoint: Before intervention, one week, 4 weeks and 12 weeks after intervention. Method of measurement: A paper strip is placed on the eye under the lower eyelid for a certain period of time. The length of the tear-soaked strip will be measured in millimeters. A positive change from baseline indicates improvement in each eye. Uncorrected visual acuity. Timepoint: Before intervention, 1week, 1 month and 3 months after intervention. Method of measurement: Measurement of vision based on Snellen chart. Best corrected visual acuity. Timepoint: Before intervention, 1week, 1 month and 3 months after intervention. Method of measurement: Measurement of vision based on Snellen chart. This study will not have any other financial source Approved 2024-01-01 Ethics Committee of Semnan University of Medical Sciences Headquarters of Smenan University of Medical Sciences, Basij Blvd. Semnan Semnan Iran (Islamic Republic of)