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Investigating the effectiveness of umbilical cord blood serum on curing eye dryness

Protocol summary

Study aim
Determining the effect of using diluted human umbilical cord blood serum in the treatment of dry eye
Design
Considering the following values and considering a 20% probability of sample loss, 32 samples or 64 eyes are ultimately required. Random assignment of patients to two groups is performed using the permuted block stratified randomization method.
Settings and conduct
Patients will first be examined by an anterior segment specialist and after confirmation of dry eye, treatment with artificial tears will be initiated, and one group will be given drops made from fetal cord blood and used simultaneously with artificial tears. The subjects will be randomly assigned to two treatment groups. After receiving the eye drops, patients will be followed up for 3 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Chronic dry eye (>3 months) unresponsive to standard treatment, with Schirmer I <5 mm, TBUT <5 s, or Oxford grade >3. Exclusion criteria: Age <18, pregnancy, contact lens use, recent ocular allergy or surgery (within 6 months), eyelid/eyelash abnormalities, and infectious diseases (HBV, HCV, HIV).
Intervention groups
Patients with dry eye disease will be randomly assigned to two groups. One group will receive artificial tears, while the other group will receive eye drops derived from fetal umbilical cord blood in combination with artificial tears. Patients will be followed for 6 months and assessed for visual acuity, dry eye questionnaire score, corneal sensitivity, tear breakup time, extent of corneal staining, tear meniscus height, and blink rate.
Main outcome variables
Visual acuity, dry eye score , corneal sensation assessment with an aesthetometer, tear breakdown time, corneal coloration extent, tear prism height, blinking frequency

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250702066328N1
Registration date: 2025-12-29, 1404/10/08
Registration timing: registered_while_recruiting

Last update: 2025-12-29, 1404/10/08
Update count: 0
Registration date
2025-12-29, 1404/10/08
Registrant information
Name
Mehraneh Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 903 904 4175
Email address
mehranejafarimums@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-16, 1404/09/25
Expected recruitment end date
2026-03-16, 1404/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of umbilical cord blood serum on curing eye dryness
Public title
Investigating the effectiveness of umbilical cord blood serum on curing eye dryness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with dry eyes for more than 3 months that do not improve with conventional treatment (such as artificial tears or ointments) Patients with dry eye who have a Type I Schirmer test of less than 5 mm Dry eye patients with Oxford test scores greater than stage 3
Exclusion criteria:
Age under 18 years Pregnancy Use of contact lenses History of ocular allergy, intraocular surgery, and/or refractive surgery within the past 6 months Anatomical changes of the eyelids and/or eyelashes Patients with infectious or transmissible diseases such as HBV, HCV, or HIV
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of patients to two groups is performed using the permuted block stratified randomization method. First, eligible patients are classified according to age and gender in the order of arrival. Then, they are assigned to the desired group based on blocks of 4 (consisting of two groups A and B and two replications for each) that are randomly selected from all possible permutations. These blocks were created using R statistical software version 4.0.2. Matching: The two groups are matched in terms of age and sex using a stratified permutation block randomization method (frequency matching). Blinding: This study uses a single blinding method, so that the technician responsible for recording the outcomes will not be aware of the intervention in question.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study uses a single blinding method, so that the technician responsible for recording the outcomes will not be aware of the intervention in question.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Motahari Boulevard, Zahedan, Sistan and Baluchestan Province, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737791
Approval date
2025-04-20, 1404/01/31
Ethics committee reference number
IR.ZAUMS.REC.1404.019

Health conditions studied

1

Description of health condition studied
Dry eye
ICD-10 code
H04
ICD-10 code description
Disorders of lacrimal system

Primary outcomes

1

Description
Determining and comparing average visual acuity in dry eye treatment
Timepoint
At the beginning of the study and the first and third months after the start of the diluted fetal umbilical cord blood serum drip
Method of measurement
It was measured based on the LogMAR method (Logarithm of the minimum angle of resolution).

2

Description
Determining and comparing the average dryness score in dry eye treatment
Timepoint
At the beginning of the study and one month and three months after starting the use of diluted fetal cord blood serum
Method of measurement
It is determined based on the OSDI questionnaire score and recorded in the information form.

3

Description
Corneal sensitivity
Timepoint
‏At the beginning of the study and one month and three months after starting the use of diluted fetal cord blood serum
Method of measurement
Corneal sensitivity

4

Description
Tear film break up time
Timepoint
‏At the beginning of the study and one month and three months after starting the use of diluted fetal cord blood serum
Method of measurement
tear film breakup time (Second)

5

Description
The height of the lacrimal prism
Timepoint
‏At the beginning of the study and one month and three months after starting the use of diluted fetal cord blood serum
Method of measurement
Tear meniscus height is measured using slit lamp examination and recorded on the information form.

6

Description
Blink frequency
Timepoint
‏At the beginning of the study and one month and three months after starting the use of diluted fetal cord blood serum
Method of measurement
It is determined based on blink rates (25%, 50%, 75% blinks, All lid closures, Extended lid closures, and Superextended lid closures) and recorded in the information form.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group:Patients in this group will receive eye drops prepared from diluted human umbilical cord blood serum in combination with standard artificial tears. The cord blood serum is diluted to a specific concentration and prepared under sterile conditions. Patients will instill one drop in each eye four times daily. The treatment duration is 6 months, with regular follow-up visits to assess the effect on visual acuity, dry eye questionnaire score, corneal sensitivity, tear breakup time, extent of corneal staining, tear meniscus height, and blink rate.
Category
Treatment - Drugs

2

Description
Control group: Patients in this group will receive only standard artificial tears, instilled one drop in each eye four times daily. The follow-up schedule and assessment parameters are the same as in the intervention group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Ophthalmology Hospital
Full name of responsible person
Mehraneh Jafari
Street address
Motahari Boulevard, Zahedan, Sistan and Baluchestan Province, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737791
Phone
+98 903 904 4175
Email
Mehranejafarimums@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Alireza Ansari Moghaddam
Street address
Motahari Boulevard, Zahedan, Sistan and Baluchestan Province, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737791
Phone
+98 903 904 4175
Email
Mehranejafarimums@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mehraneh Jafari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Motahari Boulevard, Zahedan, Sistan and Baluchestan Province, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737791
Phone
54333372113
Email
Mehranejafarimums@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohammadhossein Validad
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Motahari Boulevard, Zahedan, Sistan and Baluchestan Province, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737791
Phone
+98 54 3337 2113
Email
Mhovalidad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mehraneh Jafari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Motahari Boulevard, Zahedan, Sistan and Baluchestan Province, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737791
Phone
+98 903 904 4175
Email
Mehranejafarimums@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Some of the information related to the main outcome, such as age, gender, and level of education, will be shared temporarily.
When the data will become available and for how long
Access period begins after results are printed.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers working in academic and scientific institutions
From where data/document is obtainable
email:mehranejafarimums@gmail.com
What processes are involved for a request to access data/document
Providing job information, educational qualifications, and the reason for requesting the file
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