ISRCTN21989763Completed未知
Fish scale based ologen™ Biocornea for the emergency management of corneal perforations
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Aeon Astron Europe B.V.
- Enrollment
- 7
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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