Autologous Serum Eye Drops in Dry Eye Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorThe General Authority for Teaching Hospitals and Institutes
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged less than 18 years.
Both sexes.
Diagnosed with moderate to severe dry eye syndrome (DES) refractory to artificial tears.
Disqualifiers
Active ocular infection.
Recent ocular surgery.
Systemic immunosuppressive therapy.
History of allergy to blood-derived products.
Trial design
Design model
Single group
Treatments tested in this trial
Autologous Serum Eye Drop
Other interventionParticipants 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 groups
70 Participants
are divided into 1 treatment groupGroup A: Study groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Visual acuity
Visual acuity will be measured.
Time frame
12 weeks post-procedureSecondary outcomes
1
Improvement in Ocular Surface Disease Index (OSDI)
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.
Time frame
12 weeks post-procedure2
Incidence of adverse events
Incidence of adverse events will be recorded.
Time frame
12 weeks post-procedureSponsors and contacts
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Source ClinicalTrials.gov