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Evaluation effect of umbilical cord blood serum drops in the treatment of severe dry eye

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230925059512N1
Enrollment
30
Registered
2024-08-11
Start date
2024-08-22
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1- Sjogren's syndrome patients with severe dry eyes 2- Mustard gas chemical veterans with severe dry eyes. Other disorders of lacrimal gland (Dry eye syndrome )

Interventions

Intervention 1: 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 dr

Sponsors

Bagheiat-allah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Severe dry eye sign and symptoms. Timepoint: before the intervention and 1 and 2 months after the intervention. Method of measurement: 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

MeasureTime frame
Visual acuity status. Timepoint: Before the intervention and 1 and 2 months after the intervention, vision evaluation is done. Method of measurement: We record the acuity of patients based on the logarithm of the minimum angle of resolution (log MAR) at each follow-up.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Aghamolai

Bagheiat-allah University of Medical Sciences

aghamolaei22@gmail.com+98 21 8861 7711

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026