Autologous Serum Eye Drops in Dry Eye Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous Serum Eye Drop.
- Who it may be relevant to
- Registry conditions: Autologous Serum Eye Drops, Dry Eye Syndrome. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Autologous Serum Eye Drops in Dry Eye Syndrome: Clinical Efficacy and Safety Evaluation
Overview
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
- Other Autologous 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.
Primary outcome measures
- Visual acuity [Time frame: 12 weeks post-procedure]
Secondary outcome measures (2)
- Improvement in Ocular Surface Disease Index (OSDI) [Time frame: 12 weeks post-procedure]
- Incidence of adverse events [Time frame: 12 weeks post-procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- The General Authority for Teaching Hospitals and Institutes — Cairo
Identifiers
NCT: NCT07295691 · HSO00010