Autologous Serum Eye Drops in Dry Eye Syndrome

The General Authority for Teaching Hospitals and Institutes

Status: Enrolling

Conditions: Autologous Serum Eye Drops; Dry Eye Syndrome

Treatments: Other: Autologous Serum Eye Drop

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT07295691

HSO00010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Study group

Experimental group

Description:

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.

Treatment:

Other: Autologous Serum Eye Drop