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.
≥ 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.
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;
Single group
Autologous Serum 20%
DrugThe collection of autologous serum in a closed blood processing system for ocular use
Feasibility of using the collection device under testing
Proportion of blood collections that resulted in successful production of final autologous serum containers suitable for patient use.
Median pre-freezing number of leukocytes in autologous serum
0.0-0.03x10ˆ3/mcL;
Median pre-freezing number of red blood cells in autologous serum
0.0-0.03x10ˆ6/mcL;
Median pre-freezing number of platelets in autologous serum
0.0-0.03x10ˆ3/mcL;
Median pre and post-freezing pH in autologous serum
7.00-7.50;
Pre- and post-growth factor in autologous serum
EGF, PDGF, NGF, Substance P, hialuronic acida, vitamin A and Vitamin D
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GIANCARLO FATOBENE
Lead sponsor
University of Sao Paulo General Hospital
Sponsor institution
JP Farma
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
