Protocol summary
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Study aim
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Determining the effect of umbilical cord serum drops in improving dry eye symptoms and the amount of epithelium regeneration in patients with dry eye syndrome.
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Design
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The clinical trial has a control group with two measurements in the follow-up and randomized block in three groups, Sjogren's patients and mustard gas chemical veterans, and phase 2 of the clinical trial is used on 30 patients.
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Settings and conduct
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The location of the study is the Eye Clinic of Baqiyatallah Hospital.
In laboratory conditions, cord blood donor samples are screened for infectious viral pathogens such as human immunodeficiency virus, syphilis, and hepatitis B and C. Patient dry eye symptoms score, visual acuity, tear film breakup time, Schirmer test, fluorescein staining test of cornea and conjunctiva are evaluated and recorded to evaluate the amount of tissue damage before treatment and one month and 2 months after treatment.
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Participants/Inclusion and exclusion criteria
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Patients with Sjogren's syndrome and severe dry eyes, as well as chemical eye injuries caused by mustard gas, who do not respond well to conventional dry eye treatments will be included in the study.
Patients who have infection and inflammation not related to dry eye, use of contact lenses, eye allergies, and a history of surgery and eyelid and eyelash abnormalities, as well as pregnant or breastfeeding women, will excluded in the study.
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Intervention groups
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In the intervention group, drops of umbilical cord blood serum are used to treat the symptoms of dry eyes and tissue destruction of the external surfaces of the eyes, and in the control group, conventional methods of dry eye treatment are used.
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Main outcome variables
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subjective symptoms of dry eyes; visual acuity; Tear film quality; staining of the cornea and conjunctiva
General information
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Reason for update
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Unfortunately, the study design was not stated correctly. There will be 3 groups in the study. One group of sjögren's patients who will receive the new drops, one group of sjögren's patients who will receive the conventional treatment drops and will be the control group for the previous group, and one group of mustard gas chemical veterans who will receive the new drops in one of their eyes and the conventional treatment drops in the other one and each person will be their own control. Also, the sample size was revised and there will be 10 people in each group.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230925059512N1
Registration date:
2024-08-11, 1403/05/21
Registration timing:
prospective
Last update:
2025-03-21, 1404/01/01
Update count:
1
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Registration date
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2024-08-11, 1403/05/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-08-22, 1403/06/01
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Expected recruitment end date
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2025-03-21, 1404/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation effect of umbilical cord blood serum drops in the treatment of severe dry eye in patients with Sjogren's syndrome and mustard gas chemical veterans
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Public title
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Evaluation effect of umbilical cord blood serum drops in the treatment of severe dry eye
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with Sjogren's syndrome and severe dry eyes, who do not respond well to conventional dry eye treatments
chemical eye injuries caused by mustard gas and severe dry eyes, who do not respond well to conventional dry eye treatments
low tear breakup time (less than 5 seconds)
low Schirmer test results (5 mm)
Positive fluorescein staining (≥3)
Exclusion criteria:
Patients who have infection and inflammation not related to dry eye
use of contact lenses
eye allergies
history of surgery and eyelid and eyelash abnormalities
pregnant or breastfeeding women
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Age
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No age limit
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Gender
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Both
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-06-29, 1403/04/09
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Ethics committee reference number
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IR.BMSU.BAQ.REC.1403.080
Health conditions studied
1
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Description of health condition studied
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1- Sjogren's syndrome patients with severe dry eyes 2- Mustard gas chemical veterans with severe dry eyes
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ICD-10 code
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H04.1
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ICD-10 code description
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Other disorders of lacrimal gland (Dry eye syndrome )
Primary outcomes
1
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Description
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Severe dry eye sign and symptoms
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Timepoint
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before the intervention and 1 and 2 months after the intervention
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Method of measurement
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The dry eye symptom score of the patient is subjectively used from the Persian OSDI questionnaire, whose validity and reliability have been checked in the Iranian population. Tear film breakup time test is evaluated using slit lamp with cobalt blue filter and sodium fluorescein. The Schirmer test is performed using a standardized kit containing a 5 x 30 mm filter paper strip and placed on the lower eyelid margin in the temporal area. Fluorescein staining test of cornea and conjunctiva is evaluated and recorded based on SICCA (Sjogren's International Collaborative Clinical Alliance) criteria to assess the amount of tissue damage before treatment and one month and 2 months after treatment.
Secondary outcomes
1
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Description
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Visual acuity status
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Timepoint
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Before the intervention and 1 and 2 months after the intervention, vision evaluation is done.
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Method of measurement
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We record the acuity of patients based on the logarithm of the minimum angle of resolution (log MAR) at each follow-up.
Intervention groups
1
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Description
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For the control group (Patients with Sjogren's syndrome and severe dry eye symptoms), conventional dry eye treatment methods such as artificial tear drops and topical corticosteroid drops are used and the changes are monitored. At first, the purpose of the study is simply explained and informed consent will be obtained from the participants.
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Category
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Treatment - Other
2
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Description
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Intervention group (Patients with Sjogren's syndrome and severe dry eye symptoms): After delivery, umbilical cord blood is collected immediately from expectant mothers in a sterile container without anticoagulants. Prior to procurement, respective umbilical cord donors must provide their written consent. In vitro, cord blood donor samples are screened for infectious viral pathogens such as human immunodeficiency virus (HIV), syphilis, and hepatitis B and C viruses. The collected virus-free umbilical cord blood is incubated for two to four hours at room temperature, after which the blood is centrifuged. After centrifugation, the yellow supernatant (serum) is carefully separated into a new sterile tube, and the remaining sediment of red blood cells and other cellular debris must be discarded. Heat inactivation should then be performed at 56°C for 30 minutes on collected serum followed by filtration and dilution to 20% storage at -20°C for future clinical use. Opened drops of serum should be kept in the refrigerator at a temperature of 4 degrees and unopened drops at a temperature of minus 20 degrees. Each opened drop is used for one week. Serum drops are used 4-6 times a day.
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Category
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Treatment - Drugs
3
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Description
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Intervention group (Right eye of the patients of mustard gas chemical veterans with severe dry eye symptoms): After delivery, umbilical cord blood is collected immediately from expectant mothers in a sterile container without anticoagulants. Prior to procurement, respective umbilical cord donors must provide their written consent. In vitro, cord blood donor samples are screened for infectious viral pathogens such as human immunodeficiency virus (HIV), syphilis, and hepatitis B and C viruses. The collected virus-free umbilical cord blood is incubated for two to four hours at room temperature, after which the blood is centrifuged. After centrifugation, the yellow supernatant (serum) is carefully separated into a new sterile tube, and the remaining sediment of red blood cells and other cellular debris must be discarded. Heat inactivation should then be performed at 56°C for 30 minutes on collected serum followed by filtration and dilution to 20% storage at -20°C for future clinical use. Opened drops of serum should be kept in the refrigerator at a temperature of 4 degrees and unopened drops at a temperature of minus 20 degrees. Each opened drop is used for one week. Serum drops are used 4-6 times a day.
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Category
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Treatment - Drugs
4
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Description
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For the control group (Left eye of the patients of mustard gas chemical veterans with severe dry eye symptoms), conventional dry eye treatment methods such as artificial tear drops and topical corticosteroid drops are used and the changes are monitored. At first, the purpose of the study is simply explained and informed consent will be obtained from the participants.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Bagheiat-allah University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable