About this trial
Autologous serum eye drops (ASED) are an established therapy for ocular surface diseases; however, their preparation can be costly and may not be available due to the need for germ-free conditions. This pilot trial assesses the feasibility of collecting ASED in a closed-circuit system for patients with chronic ocular surface diseases.
Eligibility criteria
Qualifiers
≥ 18 years
Dry eye and/or chronic epithelial defects of the ocular surface with indication for autologous serum according to the evaluation of ophthalmologists specialized in Cornea and Ocular Surface;
Peripheral venous access or PICC that allows the collection of whole blood.
Disqualifiers
Active ocular infection;
Hemoglobin < 11 g/dL;
Angina, MI, or stroke in the last 30 days;
Significant pulmonary or cardiac disease that contraindicates autologous serum collection in the investigator's opinion;
Trial design
Treatments tested in this trial
- Autologous Serum 20%
Treatment groups
Sponsors and collaborators
GIANCARLO FATOBENE
Lead sponsor
University of Sao Paulo General Hospital
Sponsor institution
JP Farma
Collaborator