Autologous Serum Obtained by a Closed-Circuit Collection Device (NCT07014059) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
Brazil16 participantsStarted 2025-06-20
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of using the collection device under testing