Fish scale based ologen™ Biocornea for the emergency management of corneal perforations

Aeon Astron Europe B.V.0 个研究点目标入组 7 人开始时间: 2022年7月25日最近更新: 2022年8月15日

适应症

试验速览

暂无简介。

•1. Age =18 years
•2. Perforated corneal ulceration/laceration
•3. Leaking corneal defects with indication for corneal transplantation due to:
•3.1 Perforating corneal ulceration, or
•3.2 Perforating corneal trauma with loss of corneal tissue making primary wound closure by corneal suturing impossible
•4. Only one eye is affected by corneal ulceration / perforation / laceration. The non-affected eye has the potency of a minimum visual acuity of 0.63 (20/32).
•5. No human donor cornea nor 0-cornea” is available
•6. Subject must be able and willing to cooperate with the CIP
•7. Subject must be able and willing to complete postoperative follow-up requirements
•8. Subject must be able to understand and read the German language. In case reading is difficult (eye trauma) qualified staff will read out the ICF.
•9. Subject or witness has signed the ICF

•1. Known hypersensitivity to fish collagen
•2. Pregnant or breast-feeding women.
•3. Subject is participating in any other clinical trial or research project with an investigational medicinal product or a medical device or has participated in any other trial within 30 days prior to the last visit of that study and day 0 of this study.
•4. Patients with severe general health conditions (multiple trauma, acute life-threatening diseases, high risk for general anesthesia)
•5. Subject is dependent on the sponsor or investigators in a familiar or financial manner

发起方