Studying the effect of platelet-rich plasma-derived exosome (PRP-Exosome) on the treatment of dry eye and persistent corneal defects- Interventional - before and after
To evaluate the efficacy and safety of autologous platelet-rich plasma (PRP) derived exosome eye drops in healing persistent corneal epithelial defects.
Design
Single center, single arm, pre-post interventional clinical trial without randomization, phase 1-2 pilot study on 50 patients.
Settings and conduct
Khalili Hospital, Shiraz; evaluations including slit lamp, corneal staining, visual acuity, and symptoms are done on days 0, 7, 14, and 28; no blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 years or older; persistent corneal epithelial defect unhealed for at least 2 weeks; willingness to attend 28-day follow-ups; written consent. Exclusion criteria: Active ocular infection; pregnancy or lactation; known hypersensitivity; severe systemic illness; severe thrombocytopenia.
Intervention groups
Single arm study; 50 patients receive 20% autologous PRP-derived exosome eye drops, 1 drop every 6 hours into the affected eye for 28 days.
Main outcome variables
Rate and time to complete corneal epithelial healing; corneal fluorescein staining area; best-corrected visual acuity (BCVA); clinical symptom severity score (VAS).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240706062337N3
Registration date:2026-10-05, 1405/07/13
Registration timing:prospective
Last update:2026-10-05, 1405/07/13
Update count:0
Registration date
2026-10-05, 1405/07/13
Registrant information
Name
Fatemeh Sanie-Jahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 2830
Email address
fsanie@sums.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2027-03-06, 1405/12/15
Expected recruitment end date
2028-03-05, 1406/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of platelet-rich plasma-derived exosome (PRP-Exosome) on the treatment of dry eye and persistent corneal defects- Interventional - before and after
Public title
Effect of Platelet-Rich Plasma-Derived Exosome Eye Drops in the Treatment of Dry Eye and Persistent Corneal Defects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years or older.
Clinical diagnosis of persistent corneal epithelial defect (lack of significant epithelial healing for 2 weeks or more despite standard supportive treatments) and/or dry eye-related epithelial lesions confirmed by an ophthalmologist.
Ability and willingness to comply with all study follow-up visits on days 0, 7, 14, and 28.
Provision of written informed consent after receiving comprehensive information regarding the study objectives, procedures, potential benefits, and risks.
Exclusion criteria:
Active ocular infection (corneal or conjunctival infection with purulent discharge) requiring immediate systemic or intensive topical antimicrobial therapy.
Known history of hypersensitivity or anaphylactic reaction to blood products or preservatives used in the artificial tears.
Pregnancy or breastfeeding.
Concurrent use of topical or systemic medications that substantially interfere with corneal epithelial wound healing and cannot be safely discontinued (e.g., high-dose systemic corticosteroids or potent immunosuppressive agents).
Severe uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus or end-stage renal/hepatic failure) that may compromise patient safety or treatment response.
Baseline hematological abnormalities or markedly low platelet counts that preclude the preparation of adequate-quality autologous platelet-rich plasma (PRP).
Concurrent participation in any other clinical trial that could interfere with the study interventions or outcomes.
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand Boulevard, Poostchi Street, Poostchi Ophthalmology Research Center
City
Shiraz
Province
Fars
Postal code
7134997446
Approval date
2026-07-29, 1405/05/07
Ethics committee reference number
IR.SUMS.REC.1405.317
Health conditions studied
1
Description of health condition studied
Dry eye disease
ICD-10 code
H04.129
ICD-10 code description
Dry eye syndrome of unspecified lacrimal gland
2
Description of health condition studied
Corneal epithelial defect
ICD-10 code
H59
ICD-10 code description
Intraoperative and postprocedural complications and disorders of eye and adnexa, not elsewhere classified
Primary outcomes
1
Description
Complete healing of the persistent corneal epithelial defect, defined as total re-epithelialization with negative corneal fluorescein staining
Timepoint
Before intervention (day 0) and days 7, 14, and 28 after intervention
Method of measurement
Slit lamp biomicroscopy examination combined with cobalt blue light digital photography following one percent sodium fluorescein eye drop instillation, and calculation of the defect area in square millimeters using digital image analysis software
2
Description
Improvement in dry eye disease severity based on tear break-up time (TBUT) and Ocular Surface Disease Index (OSDI) score
Timepoint
Before intervention (day 0) and days 7, 14, and 28 after intervention
Method of measurement
Measurement of tear break up time in seconds using slit lamp biomicroscopy with cobalt blue illumination following instillation of sodium fluorescein solution
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Autologous platelet-rich plasma (PRP) derived exosome eye drops. Peripheral blood is obtained from the patient, and exosomes are extracted via centrifugation and platelet lysis protocols, followed by 0.22 micrometer sterile filtration. The exosomes are diluted to a 20% volume per volume concentration in an artificial tears. Patients administer 1 drop into the affected eye four times daily (every 6 hours) for 28 consecutive days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Poostchi Ophthalmology Research Center
Full name of responsible person
Fatemeh Sanie-Jahromi
Street address
Zand Boulevard, Asadabadi Street, Poostchi Ophthalmology Research Center
City
Shraz
Province
Fars
Postal code
7134997446
Phone
+98 71 3230 2830
Email
fsanie@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Mohammadi
Street address
Zand Street, Vice Chancellor for Research, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Sanie-Jahromi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Cell Biology
Street address
Zand Boulevard, Asadabadi Street, Poostchi Ophthalmology Research Center
City
Shiraz
Province
Fars
Postal code
7134997446
Phone
+98 71 3230 2830
Email
fsanie@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Sanie-Jahromi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Cell Biology
Street address
Zand Boulevard, Poostchi Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134997446
Phone
+98 71 3230 2830
Fax
Email
fsanie@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Sanie-Jahromi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Cell Biology
Street address
Zand Boulevard, Asadabadi Street, Poostchi Ophthalmology Research Center
City
Shiraz
Province
Fars
Postal code
7134997446
Phone
+98 71 3230 2830
Email
fsanie@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available