Corneale Perforation - Biocornea

Prüfplancode ISRCTN EudraCT Clinicaltrials.gov DRKS
P-01-2014-11-001 n.a.

Notfallversorgung/Abdeckung mit einem auf Fischschuppen basierenden Gewebe bei cornealer Perforation

Status: Aktiv

Studienziel / Fragestellung

Primäres Prüfziel

To assess the safety and effectiveness of the ologen™ Biocornea to close the eye for a limited period of time up to a maximum of 72 hours in emergency patients with perforated corneal ulcerations/lacerations referred to the hospital for immediate treatment.

Sekundäre Prüfziele

None

Diagnose

Corneale Perforation

Perforated corneal ulceration/laceration

Patientenmerkmale

Einschlusskriterien

1. Age ≥ 18 years 2. Perforated corneal ulceration/laceration 3. Leaking corneal defects with indication for PK due to: a) perforating corneal ulceration b) 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 informed consent form (ICF). 9. Subject or witness has signed the ICF

Ausschlusskriterien

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

Studiendesign

Einarmig,Monozentrisch,Open Label,Prospektiv

Dokumente (passwortgeschützt)

Zuständigkeiten Gesamtstudie

Leiter der klinischen Prüfung

Prof. Dr. Björn Bachmann

Prüfzentren

Köln

Zentrum für Augenheilkunde (UK Köln)

Studienbüro

Status

Aktiv

Prüfer (Hauptprüfer im Zentrum)

Prof. Dr. Björn Bachmann

Studienkontakt im Prüfzentrum

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