Autologous Serum Eye Drops, Dry Eye Syndrome
Conditions
Brief summary
This study aims to evaluate the clinical efficacy and safety of autologous serum eye drops (ASEDs) in patients with moderate-to-severe dry eye syndrome who are refractory to conventional artificial tear therapy.
Detailed description
Dry Eye Syndrome (DES) is a highly prevalent ocular condition that significantly affects quality of life, with global prevalence estimated at 5%-50%, depending on population and diagnostic criteria. Autologous Serum Eye Drops (ASEDs) have emerged as a promising therapy due to their composition, which is rich in vitamin A, epidermal growth factor, fibronectin, and transforming growth factor-β. These components mimic natural tears and promote epithelial healing, reduce inflammation, and enhance tear film stability.
Interventions
OTHERAutologous Serum Eye Drop
Participants will receive eye drops prepared from their blood serum following a standardized protocol. Specifically, 40 mL of venous blood was collected from each participant at the start of the study and centrifuged at 3000 rpm for 15 min.
Sponsors
The General Authority for Teaching Hospitals and Institutes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children aged less than 18 years. * Both sexes. * Diagnosed with moderate to severe dry eye syndrome (DES) refractory to artificial tears.
Exclusion criteria
* Active ocular infection. * Recent ocular surgery. * Systemic immunosuppressive therapy. * History of allergy to blood-derived products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | 12 weeks post-procedure | Visual acuity will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Ocular Surface Disease Index (OSDI) | 12 weeks post-procedure | The ocular surface disease index (OSDI) is a comprehensive 12-item questionnaire used to assess the frequency and severity of eye symptoms, the influence of environmental triggers, and the impact of DES on vision-related functionality. The OSDI scores range from 0 to 100, with higher scores indicating greater ocular discomfort and impairment. |
| Incidence of adverse events | 12 weeks post-procedure | Incidence of adverse events will be recorded. |
Countries
Egypt
Contacts
Primary ContactHossam A Hassan, MD
Outcome results
None listed