Autologous Serum Obtained by a Closed-Circuit Collection Device

Launched by GIANCARLO FATOBENE · Jun 2, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to prepare eye drops made from the patient's own blood, called autologous serum eye drops (ASED). These drops are used to treat various eye conditions that cause dryness and damage to the surface of the eye, which can be uncomfortable and affect vision. The trial will explore a closed-circuit system for collecting the serum, hoping to make the preparation process easier and more accessible for patients with chronic eye issues.

To participate in this study, you need to be at least 18 years old and have specific eye problems that require ASED treatment. You should also have access to a vein for collecting blood. However, there are some health conditions that might prevent you from joining, such as active infections or serious heart and lung diseases. If you qualify, you'll attend follow-up visits at 6 and 12 weeks to check on your progress. This trial is not yet recruiting participants, but it aims to provide a safer and more efficient way to produce these beneficial eye drops for those in need.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥ 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.
• Exclusion Criteria:
• • 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;
• • Active ocular or systemic infection at the time of collection;
• • Inability to attend follow-up visits at 6 and 12 weeks;
• • Active hematological malignancy (except measurable residual disease) or solid malignancy (except non-melanoma skin cancer);
• • Positive for HIV, HCV, HBV, HTLV, Chagas disease, or syphilis;
• • Life expectancy \< 6 months;
• • Not pregnant (as reported by the participant).