Dry Eye Disease (DED)
Conditions
Keywords
Dry Eye Disease-DED, Autologous Serum, Autologous Platelet Lysate, Cord Blood Platelet Lysate
Brief summary
In this study, patients are randomly assigned to the study groups (autologous peripheral blood, umbilical cord blood, autologous serum). Each patient, who wishes to undergo any treatment, has the right to be informed about their disease and the recommended treatment by the treating physician so that they can decide whether to proceed with it or not. During the study, you will need to complete an eye symptom assessment questionnaire (Ocular Surface Disease Index - OSDI).
Interventions
BIOLOGICALAutologous serum eyedrops
For Autologous Serum preparation, 50 ml of peripheral blood were collected and centrifuged at 4000 g at +8°C for 15 minutes. A total of 3.5 ml of saline from preservative free eye drops was replaced with 3.5 ml of autologous serum. Infectious disease screening matched that of the PL group. Final products were stored for one week at +4°C and up to four weeks at -20°C.
BIOLOGICALAutologous Platelet Lysate
Fifty milliliters of peripheral blood were collected in anticoagulated tubes and centrifuged at 900 g for 10 minutes to isolate platelet rich plasma (PRP). PRP was diluted to 30% (v/v) with sterile saline, frozen at -80°C for at least 60 minutes (thermal shock), and rapidly thawed at 4°C to induce platelet lysis. The resulting PL was aliquoted into sterile containers and stored at -20°C for approximately 45 days. On the day of use, vials were thawed at 4°C. After production, the eye drops were placed in sterile 5 ml and 10 ml containers with a dropper tip
BIOLOGICALUmbilical Cord Blood Platelet Lysate
CB derived PL was produced based on the PL production process according to the already published protocol of the Hellenic Cord Blood Bank (HCBB) using cord blood units from full term pregnancies (38-40 weeks) that were unsuitable for transplantation according to the criteria of the World Accreditation Organization "FACT-NetCord" but donated for research with informed consent which was obtained prior to delivery and was in accordance with the National Bioethics Committee according to Helsinki declaration. PRP was isolated via double centrifugation, frozen at -80°C for at least 24 hours, and rapidly thawed at 37°C to release platelet derived growth factors. The lysate was filtered through a 0.22 μm non pyrogenic filter and aliquoted into 5-10 ml vials. Up to 10 ml of PL were obtained per cord blood unit. CB eye drops were stored at -20°C for up to 30 days without measurable loss of growth factor content.
Sponsors
G.Gennimatas General Hospital
Biomedical Research Foundation of the Academy of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age\>18years * Dry Eye Disease in chronic blepharitis * Dry Eye Disease in Sjogren syndrome * Toxic keratopathy/Dry Eye Disease after use of anti-glaucoma eye drops
Exclusion criteria
* Age\<18years * Active infectious disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Dry Eye Disease parameters (Total Break-Up time) | From enrollment to the end of treatment at 4 weeks | For the assessment of the stability of the tear film, its breakup time was examined, that is, the time between the last blink and the appearance of the first dry spot after instillation of 2% fluorescein into the eye. A time of less than 5 seconds is considered indicative of ocular surface disease. |
| Improvement of Dry Eye Disease parameters (Schirmer test) | From enrollment to the end of treatment at 4 weeks | For the assessment of tear production, the Schirmer test was used (amount of wetting of a special filter paper), the examination was performed without the use of local anesthesia. If the length of wetting after 5 minutes is less than 10 mm, then it is considered pathological. |
| Improvement of Dry Eye Disease parameters (Oxford Grading Scale) | From enrollment to the end of treatment at 4 weeks | The Oxford Scale grades ocular surface staining from 0 to 5, where 0 indicates no staining and 5 indicates severe corneal damage. It measures the severity of corneal staining using dyes like fluorescein. |
| Improvement of Dry Eye Disease parameters (Ocular Surface Disease Index-OSDI) | From enrollment to the end of treatment at 4 weeks | The OSDI is a 12-item questionnaire assessing ocular symptoms, visual functioning, and environmental triggers. Each is scored 0-4 and converted to a 0-100 total score. Scores classify as normal, mild, moderate, severe. |
Countries
Greece
Contacts
STUDY_CHAIRKonstantinos Droutsas, Associate Professor Ophthalmol
1st Department of Ophthalmology at the G. Gennimatas General Hospital in Athens, Greece
STUDY_DIRECTORGeorgios Kymionis, Professor in Ophthalmology
1st Department of Ophthalmology at the G. Gennimatas General Hospital in Athens, Greece
STUDY_DIRECTORDimitris Papaconstantinou, Professor in Ophthalmology
1st Department of Ophthalmology at the G. Gennimatas General Hospital in Athens, Greece
Outcome results
None listed