Closure of perforated corneal ulceration or laceration Eye Diseases
Conditions
Interventions
ologen™ Biocornea was applied with the aim to close the corneal wound when the patients fulfilled all inclusion criteria and none of the exclusion criteria. The device was implanted in the operation r
Sponsors
Aeon Astron Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Severe inflammatory anterior chamber reaction measured using slit lamp examination at days 1, 2, 3, 4 (exam before removal of ologen™ Biocornea and penetrating keratoplasty) and 5. 2. Ocular hypotony measured by palpation of the eye at days 0 (screening), 1, 2, 3, 4 (exam before removal of ologen™ Biocornea and penetrating keratoplasty) and 5. 3. Suprachoroidal hemorrhage measured using ultrasound examination at days 1, 2, 3, 4 (exam before removal of ologen™ Biocornea and penetrating keratoplasty) and 5. 4. Choroidal detachment measured using ultrasound examination at days 1, 2, 3, 4 (exam before removal of ologen™ Biocornea and penetrating keratoplasty) and 5. 5. Flat anterior chamber measured using slit lamp examination at days 1, 2, 3, 4 (exam before removal of ologen™ Biocornea and penetrating keratoplasty) and 5. 6. Endophthalmitis measured using ultrasound examination at days 1, 2, 3, 4 (exam before removal of ologen™ Biocornea and penetrating keratoplasty) and 5. 7. Wound leakage measured using the Seidel test at days 1, 2, 3, 4 (exam before removal of ologen™ Biocornea and penetrating keratoplasty) and 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| AEs and potential side effects caused by the implantation of ologen™ Biocornea indicating inflammation or any other type of immune response measured using slit lamp examination at days 1, 2, 3, 4 (exam before removal of ologen™ Biocornea and penetrating keratoplasty) and 5. | — |
Countries
Germany
Contacts
Public ContactBjörn Bachmann
Outcome results
None listed