Biomaterial made from fish scales for short-term closure of defects affecting the entire thickness of the cornea
| ISRCTN | ISRCTN21989763 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21989763 |
| Secondary identifying numbers | Eudamed: CIV-15-03-013305; Sponsor's Protocol Code Number P-01-2014-11-001 |
- Submission date
- 19/04/2022
- Registration date
- 25/07/2022
- Last edited
- 25/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
There are many diseases of the cornea (clear, protective outer layer of the eye) that can lead to corneal a hole (perforation). Since in this situation there is direct access germs can penetrate the interior of the eye through such a defect and cause severe destruction. Furthermore, the liquid that fills the inside flows out through the defect, which causes the pressure inside the eye to drop. If the pressure in the eye is very low, destructive bleedings inside the eye can occur. These consequences of a penetrating corneal perforation often result in permanent visual impairment. For this reason, penetrating corneal perforations are treated as emergencies. The perforations can be closed with corneal tissue from deceased persons, but such tissue is not available at short notice in most regions of the world. A novel product called ologen™ Biocornea is used to temporarily close such corneal perforations until corneal tissue from deceased persons is available. This product is made from fish scales of a tilapia fish species. Fish scales are a by-product of this very frequently processed edible fish. The fish scales consist of a similar basic substance to the human cornea, collagen. The Biocornea is used to close the defect for a maximum of 72 hours until human corneal tissue for replacement is available. The aim of the study is to investigate whether ologen™ Biocornea can be used to close corneal defects sufficiently without causing additional damage to the eye.
Who can participate?
Patients eligible to participate in the trial had to present in an emergency situation with a corneal hole in need of human donor tissue for closure of the defect.
For inclusion in the study, only one eye could be affected by a corneal defect.
What does the study involve?
The study involves closure of the defect with ologen™ Biocornea for a maximum of 72 hours until
Replacement with human donor cornea.
What are the possible benefits and risks of participating?
The benefits are immediate closure of the corneal defect lowering the risks of intraocular
infection and bleeding.
Where is the study run from?
The study was run by the company Aeon Astron Europe B.V. (Leiden, Netherlands) as the sponsor and took place at the University eye clinics in Cologne and Bochum (Germany).
When is the study starting and how long is it expected to run for?
June 2014 to May 2020.
Who is funding the study?
This project has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under Grant Agreement No. 667400-2.
Who is the main contact?
Prof. Björn Bachmann
bjoern.bachmann@uk-koeln.de
Contact information
Public
University of Cologne
Faculty of Medicine and University Hospital Cologne
Department of Ophthalmology
Kerpener Str. 62
Cologne
50937
Germany
 ORCID ID |
0000-0002-3974-7609 |
|---|---|
| Phone | +49 221 4320 |
| bjoern.bachmann@uk-koeln.de |
Study information
| Study design | Prospective uncontrolled interventional multicenter pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Fish scale based ologen™ Biocornea for the emergency management of corneal perforations |
| Study objectives | ologen™ Biocornea is a transparent collagen scaffold that is composed of type I collagen originating from fish scales. It is designed for the emergency surgery of corneal perforation and functions as a temporary protective barrier to seal the wound and maintain the integrity of the anterior chamber for a maximum of 72 hours. |
| Ethics approval(s) | Approved 10/07/2015, Ethics Committee of the Medical Faculty of the University of Cologne (Gleueler Str. 269, 50935 Köln, Germany; +49 221 478 4262; ek-med@uni-koeln.de), ref: 15-112 |
| Health condition(s) or problem(s) studied | Closure of perforated corneal ulceration or laceration |
| Intervention | 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 room under standard operating aseptic conditions. An unstable anterior chamber was filled by either air or viscoelastic through a peripheral paracentesis. Prolapsed non-necrotic iris tissue was repositioned into the anterior chamber. Obvious necrotic prolapsed tissue was removed. Thereafter, the device was applied to the recipient’s cornea aligning the centre of the ologen™ Biocornea with the corneal defect. The ologen™ Biocornea was then fixed onto the cornea by intrastromal 10-0 nylon single sutures. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | ologen™ Biocornea |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 12/06/2014 |
| Completion date | 05/05/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 13 |
| Total final enrolment | 7 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/04/2016 |
| Date of final enrolment | 17/07/2019 |
Locations
Countries of recruitment
- Germany
Study participating centre
Cologne
50937
Germany
Sponsor information
Industry
J.H. Oortweg 19
Leiden
2333 CH
Netherlands
| Phone | +31 71 3322280 |
|---|---|
| hans.schuitmaker@aeonastron.com |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- EU Framework Programme for Research and Innovation, Horizon 2020 - Research and Innovation Framework Programme, European Union Framework Programme for Research and Innovation
Results and Publications
| Intention to publish date | 01/07/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data sets generated and/or analysed as part of the study are stored in a repository that is not publicly accessible on a server at the University of Cologne and are made available on request for e.g. scientific purposes after consultation with our ethics committee. |
Editorial Notes
12/05/2022: Trial's existence confirmed by University of Koln.
