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Erschienen in: Spektrum der Augenheilkunde 6/2014

01.12.2014 | original article

The fully synthetic, bio-coated MIRO® CORNEA UR keratoprosthesis: development, preclinical testing, and first clinical results

verfasst von: Prof. Dr. Gernot I. W. Duncker, MD, Joachim Storsberg, PhD, Wolfgang G. K. Müller-Lierheim, PhD

Erschienen in: Spektrum der Augenheilkunde | Ausgabe 6/2014

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Summary

Background

The MIRO® CORNEA UR is a new keratoprosthesis made of a single piece of flexible, hydrophobic acrylic polymer. The geometry is based on the original Cardona design, allowing epicorneal as well as intrastromal implantation. The haptic is coated with genetically engineered fibronectin, supporting the adherence of surrounding tissue. The flexibility of the haptic minimizes shear stress between keratoprosthesis and ocular tissue, and supports intraocular pressure monitoring in patients with a high incidence of glaucoma.

Material and methods

The MIRO® CORNEA UR was implanted into one eye each of four corneally blind patients suffering from autoimmune disease or severe burns. The haptic was implanted in a pocket between the ocular globe and beforehand transplanted autologous buccal mucosa, and additionally secured by a skirt of donor sclera or a collagen membrane.

Results

In three out of four eyes, the surrounding tissue firmly adhered to the haptic and penetrated the holes in the haptic. Throughout the follow-up period of 20–52 months, the haptics were firmly integrated into the surrounding tissue without signs of inflammation. Postoperative medication included antibiotics and cortisone drops. The eyes remained stable, well pressurized and free from infection. Neither tissue melting nor ingrowth of epithelial cells along the tissue–keratoprosthesis interface were observed.

Conclusions

The MIRO® CORNEA UR keratoprosthesis may be an alternative to the osteo-odonto-keratoprosthesis (OOKP) in the treatment of corneally blind patients with autoimmune disease or severe burns. In the future, indications may include deep corneal vascularization for example after ocular infection.
Literatur
1.
Zurück zum Zitat WHO. Global data on visual impairments 2010. Geneva: World Health Organization; 2012. WHO. Global data on visual impairments 2010. Geneva: World Health Organization; 2012.
2.
Zurück zum Zitat Zirm E. Eine erfolgreiche totale Keratoplastik. Albrecht v Graefes Arch Ophthalmol. 1906;64:580–93.CrossRef Zirm E. Eine erfolgreiche totale Keratoplastik. Albrecht v Graefes Arch Ophthalmol. 1906;64:580–93.CrossRef
3.
Zurück zum Zitat Zirm EK. Eine erfolgreiche totale Keratoplastik (a successful total keratoplasty). 1906. Refract Corneal Surg. 1989;5(4):258–61.PubMed Zirm EK. Eine erfolgreiche totale Keratoplastik (a successful total keratoplasty). 1906. Refract Corneal Surg. 1989;5(4):258–61.PubMed
4.
Zurück zum Zitat Liekfeld A. Keratoplastik: Indikationen und Techniken. Concept Ophthalmol. 2010;3:36–7. Liekfeld A. Keratoplastik: Indikationen und Techniken. Concept Ophthalmol. 2010;3:36–7.
5.
Zurück zum Zitat Cursiefen C. Hornhauttransplantation: Glänzende Bilanz und viele Perspektiven. Dtsch Ärztebl. 2005;102(45):A3078–80. Cursiefen C. Hornhauttransplantation: Glänzende Bilanz und viele Perspektiven. Dtsch Ärztebl. 2005;102(45):A3078–80.
6.
Zurück zum Zitat Hille K, Landau H, Ruprecht KW. [Osteo-odonto-keratoprosthesis. A summary of 6 years surgical experience]. Ophthalmologe. 2002;99(2):90–5.PubMedCrossRef Hille K, Landau H, Ruprecht KW. [Osteo-odonto-keratoprosthesis. A summary of 6 years surgical experience]. Ophthalmologe. 2002;99(2):90–5.PubMedCrossRef
7.
Zurück zum Zitat Heiligenhaus A, et al. Empfehlungen zur Diagnostik und Therapie beim Schleimhautpemphigoid am Auge. Berlin: Arbeitsgruppe Immunologie und Infektiologie der Sektion Kornea der Deutschen Ophthaklmologischen Gesellschaft DOG; http://www.dog.org/?cat=121#8 (2005). Heiligenhaus A, et al. Empfehlungen zur Diagnostik und Therapie beim Schleimhautpemphigoid am Auge. Berlin: Arbeitsgruppe Immunologie und Infektiologie der Sektion Kornea der Deutschen Ophthaklmologischen Gesellschaft DOG; http://​www.​dog.​org/​?​cat=​121#8 (2005).
8.
Zurück zum Zitat Schöpf E, et al. Toxic epidermal necrolysis and Stevens-Johnson syndrome. An epidemiologic study from West Germany. Arch Dermatol. 1991;127(6):839–42.PubMedCrossRef Schöpf E, et al. Toxic epidermal necrolysis and Stevens-Johnson syndrome. An epidemiologic study from West Germany. Arch Dermatol. 1991;127(6):839–42.PubMedCrossRef
9.
Zurück zum Zitat Mockenhaupt M, et al. Epidemiology of staphylococcal scalded skin syndrome in Germany. J Invest Dermatol. 2005;124(4):700–3.PubMedCrossRef Mockenhaupt M, et al. Epidemiology of staphylococcal scalded skin syndrome in Germany. J Invest Dermatol. 2005;124(4):700–3.PubMedCrossRef
10.
Zurück zum Zitat Lund OE. [Use of synthetic implants in the cornea and conjunctiva. Keratoprosthesis]. Ber Zusammenkunft Dtsch Ophthalmol Ges. 1978;75:173–80.PubMed Lund OE. [Use of synthetic implants in the cornea and conjunctiva. Keratoprosthesis]. Ber Zusammenkunft Dtsch Ophthalmol Ges. 1978;75:173–80.PubMed
11.
Zurück zum Zitat Lund OE. [Limits and possibilities of optical keratoprosthesis. A clinical and histopathological report (author’s transl)]. Klin Monatsbl Augenheilkd. 1982;180(1):3–12.PubMedCrossRef Lund OE. [Limits and possibilities of optical keratoprosthesis. A clinical and histopathological report (author’s transl)]. Klin Monatsbl Augenheilkd. 1982;180(1):3–12.PubMedCrossRef
12.
Zurück zum Zitat Sommer G. Keratoprothetik (Teil 1). Folia Ophthal. 1984;9:-129–37 (Leipzig). Sommer G. Keratoprothetik (Teil 1). Folia Ophthal. 1984;9:-129–37 (Leipzig).
13.
Zurück zum Zitat Sommer G. Keratoprothetik (Teil 2). Folia Ophthal. 1984;9:-189–202 (Leipzig). Sommer G. Keratoprothetik (Teil 2). Folia Ophthal. 1984;9:-189–202 (Leipzig).
14.
Zurück zum Zitat Sommer G. Keratoprothetik (Teil 3). Folia Ophthal. 1984;-9:285–91 (Leipzig). Sommer G. Keratoprothetik (Teil 3). Folia Ophthal. 1984;-9:285–91 (Leipzig).
15.
Zurück zum Zitat Hille K. [Keratoprostheses. Historical overview, materials and status of current research]. Ophthalmologe. 2002;99(7):513–22.PubMedCrossRef Hille K. [Keratoprostheses. Historical overview, materials and status of current research]. Ophthalmologe. 2002;99(7):513–22.PubMedCrossRef
16.
Zurück zum Zitat Gomaa A, Comyn O, Liu C. Keratoprostheses in clinical practice—a review. Clin Exp Ophthalmol. 2010;38(2):211–24.CrossRef Gomaa A, Comyn O, Liu C. Keratoprostheses in clinical practice—a review. Clin Exp Ophthalmol. 2010;38(2):211–24.CrossRef
17.
Zurück zum Zitat Cardona H. Keratoprosthesis with a plastic fiber meshwork supporting plate. Report of an experimental and comparative histologic study. Am J Ophthalmol. 1967;64(2):228–33.PubMedCrossRef Cardona H. Keratoprosthesis with a plastic fiber meshwork supporting plate. Report of an experimental and comparative histologic study. Am J Ophthalmol. 1967;64(2):228–33.PubMedCrossRef
18.
Zurück zum Zitat Cardona H. Keratoprosthesis; acrylic optical cylinder with supporting intralamellar plate. Am J Ophthalmol. 1962;54 :284–94.PubMedCrossRef Cardona H. Keratoprosthesis; acrylic optical cylinder with supporting intralamellar plate. Am J Ophthalmol. 1962;54 :284–94.PubMedCrossRef
19.
Zurück zum Zitat Cardona H. Anterior and posterior mushroom keratoprostheses. An experimental study. Am J Ophthalmol. 1966;61(3):498–504.PubMedCrossRef Cardona H. Anterior and posterior mushroom keratoprostheses. An experimental study. Am J Ophthalmol. 1966;61(3):498–504.PubMedCrossRef
20.
Zurück zum Zitat Cardona H. Mushroom transcorneal keratoprosthesis (bolt and nut). Am J Ophthalmol. 1969;68(4):604–12.PubMedCrossRef Cardona H. Mushroom transcorneal keratoprosthesis (bolt and nut). Am J Ophthalmol. 1969;68(4):604–12.PubMedCrossRef
21.
Zurück zum Zitat Dohlman CH, et al. Collar-button prosthesis glued to a corneal graft. In: Polack FM, editor. Cornea and external diseases of the eye. First Inter-American Symposium. Springfield: Charles C. Thomas; 1970. pp. 189–92. Dohlman CH, et al. Collar-button prosthesis glued to a corneal graft. In: Polack FM, editor. Cornea and external diseases of the eye. First Inter-American Symposium. Springfield: Charles C. Thomas; 1970. pp. 189–92.
22.
Zurück zum Zitat Strampelli B. [Osteo-odonto-keratoprosthesis]. Ann Ottalmol Clin Ocul. 1963;89:1039–44.PubMed Strampelli B. [Osteo-odonto-keratoprosthesis]. Ann Ottalmol Clin Ocul. 1963;89:1039–44.PubMed
23.
Zurück zum Zitat Girard LJ, et al. Prosthetosclerokeratoplasty-implantation of a keratoprosthesis using full-thickness onlay sclera and sliding conjunctival flap. Trans Am Acad Ophthalmol Otolaryngol. 1969;73(5):936–61.PubMed Girard LJ, et al. Prosthetosclerokeratoplasty-implantation of a keratoprosthesis using full-thickness onlay sclera and sliding conjunctival flap. Trans Am Acad Ophthalmol Otolaryngol. 1969;73(5):936–61.PubMed
24.
Zurück zum Zitat Deutschmann S. Probleme um die Entwicklung von Keratoprothesen. Augenoptik. 1978;95:8–11. Deutschmann S. Probleme um die Entwicklung von Keratoprothesen. Augenoptik. 1978;95:8–11.
25.
Zurück zum Zitat Jähne MG. [25 years Cardona keratoprosthesis after severe chemical eye burns–long-term outcome of 4 eyes]. Klin Monbl Augenheilkd. 2000;216(4):191–6.PubMedCrossRef Jähne MG. [25 years Cardona keratoprosthesis after severe chemical eye burns–long-term outcome of 4 eyes]. Klin Monbl Augenheilkd. 2000;216(4):191–6.PubMedCrossRef
26.
Zurück zum Zitat Falcinelli GC, et al. Osteo Odonto Keratoprosthesis Up to Date. Acta XXV Concilium Ophthalmologicum: proceedings of the XXVth International Congress of Ophthalmology; 4–10 May 1986; Rome, Italy. Amsterdam: Kugler and Ghedini; 1987. p. 2772–6. Falcinelli GC, et al. Osteo Odonto Keratoprosthesis Up to Date. Acta XXV Concilium Ophthalmologicum: proceedings of the XXVth International Congress of Ophthalmology; 4–10 May 1986; Rome, Italy. Amsterdam: Kugler and Ghedini; 1987. p. 2772–6.
27.
Zurück zum Zitat Falcinelli GC, et al. Osteoodontokeratoprosthesis: present experience and future prospects. Refract Corneal Surg. 1993;9:193. Falcinelli GC, et al. Osteoodontokeratoprosthesis: present experience and future prospects. Refract Corneal Surg. 1993;9:193.
28.
Zurück zum Zitat Hille K, et al. Standards for modified osteoodontokeratoprosthesis (OOKP) surgery according to Strampelli and Falcinelli: the Rome-Vienna Protocol. Cornea. 2005;24(8):895–908.PubMedCrossRef Hille K, et al. Standards for modified osteoodontokeratoprosthesis (OOKP) surgery according to Strampelli and Falcinelli: the Rome-Vienna Protocol. Cornea. 2005;24(8):895–908.PubMedCrossRef
29.
Zurück zum Zitat Zerbe BL, Belin MW, Ciolino JB. Results from the multicenter Boston Type 1 Keratoprosthesis Study. Ophthalmology. 2006;113(10):1779.e1–7.CrossRef Zerbe BL, Belin MW, Ciolino JB. Results from the multicenter Boston Type 1 Keratoprosthesis Study. Ophthalmology. 2006;113(10):1779.e1–7.CrossRef
30.
Zurück zum Zitat Storsberg J, et al. Künstliche Augenhornhaut: Biomaterialentwicklung eines ophthalmologischen Implantats mit biomimetischen Funktionalitäten. DZKF Dtsch Z Klinische Forsch. 2011;5/6:58–61. Storsberg J, et al. Künstliche Augenhornhaut: Biomaterialentwicklung eines ophthalmologischen Implantats mit biomimetischen Funktionalitäten. DZKF Dtsch Z Klinische Forsch. 2011;5/6:58–61.
31.
Zurück zum Zitat Kobuch KA, et al. Towards an artificial cornea: evaluation of a new designed hydrophobic one-material implant with modified surfaces in vitro and in vivo. ARVO Meeting Abstracts. 2008;49:5706. Kobuch KA, et al. Towards an artificial cornea: evaluation of a new designed hydrophobic one-material implant with modified surfaces in vitro and in vivo. ARVO Meeting Abstracts. 2008;49:5706.
32.
Zurück zum Zitat D.o.O.D. Intraocular and Corneal Implants Branch, Office of Device Evaluation, editor. Guidance on 510(k) Submissions for Keratoprostheses. Rockville: Center for Devices and Radiological Health CDRH, US Food and Drug Administration FDA; 1999. D.o.O.D. Intraocular and Corneal Implants Branch, Office of Device Evaluation, editor. Guidance on 510(k) Submissions for Keratoprostheses. Rockville: Center for Devices and Radiological Health CDRH, US Food and Drug Administration FDA; 1999.
33.
Zurück zum Zitat Kobuch K, et al. The MIRO® KPro—a new designed one-material implant with modified surfaces: histological evaluation of biointegration and stability in vitro, in vivo and after first clinical applications. Abstract Book, KPro Study Group, 9th KPro Meeting, April 12, 2014. Salzburg. Kobuch K, et al. The MIRO® KPro—a new designed one-material implant with modified surfaces: histological evaluation of biointegration and stability in vitro, in vivo and after first clinical applications. Abstract Book, KPro Study Group, 9th KPro Meeting, April 12, 2014. Salzburg.
34.
Zurück zum Zitat Schrage N, Hille K, Cursiefen C. Aktuelle Versorgungsmöglichkeiten mit Keratoprothesen: Boston KPro, Osteoodontokeratoprothese (OOKP), Miro Cornea und KeraClear. Der Ophthalmologe. 2014;111(11):1010–18. Schrage N, Hille K, Cursiefen C. Aktuelle Versorgungsmöglichkeiten mit Keratoprothesen: Boston KPro, Osteoodontokeratoprothese (OOKP), Miro Cornea und KeraClear. Der Ophthalmologe. 2014;111(11):1010–18.
Metadaten
Titel
The fully synthetic, bio-coated MIRO® CORNEA UR keratoprosthesis: development, preclinical testing, and first clinical results
verfasst von
Prof. Dr. Gernot I. W. Duncker, MD
Joachim Storsberg, PhD
Wolfgang G. K. Müller-Lierheim, PhD
Publikationsdatum
01.12.2014
Verlag
Springer Vienna
Erschienen in
Spektrum der Augenheilkunde / Ausgabe 6/2014
Print ISSN: 0930-4282
Elektronische ISSN: 1613-7523
DOI
https://doi.org/10.1007/s00717-014-0243-4

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