April 2010
Volume 51, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2010
First Implantation of the Aachen-TEXKPRO in Humans
Author Affiliations & Notes
  • N. F. Schrage
    Ophthalmology, County Hospital Cologne, Cologne, Germany
    Aachen Center of Technologytransfer in Ophthalmology ACTO e.V., Karlsburgweg 9, D-52070 Aachen, Germany
  • M. Frentz
    Ophthalmology, University Clinic of Aachen, Aachen, Germany
  • Footnotes
    Commercial Relationships  N.F. Schrage, Inventor and Developer, P; M. Frentz, Developer, P.
  • Footnotes
    Support  Griebel Stiftung 2004-2006; ACTO e.V. 2002-2009, IZKF BIOMAT TV10
Investigative Ophthalmology & Visual Science April 2010, Vol.51, 1152. doi:
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      N. F. Schrage, M. Frentz; First Implantation of the Aachen-TEXKPRO in Humans. Invest. Ophthalmol. Vis. Sci. 2010;51(13):1152.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : The evaluation of keratoprostheses of textile composite keratoprostheses with soft optics up to now has not been done. We produced a new type of keratoprosthesis (ACTO-TexKPRO), that uses a woven approved non resorbable suture material textile vulcanized to a silicone optics. After confirmation of ethic commitée to we developed an anterior-posterior surgical approach and started implantation on persons with bilateral blindness and severe alteration of the anterior and posterior segment on one eye.

Methods: : surgical approach was redressing conjunctiva from cornea and sclera, small 5 to 6 mm trephination, excision of lens, iris, complete vitrectomy, attaching retina, Shooter-Implantation of the keratoprosthesis with unfolding of inner and outer textile being sutured separately transscleral, then filling of the globe with silicone oil.

Results: : In total we implanted 4 keratoprostheses. In two cases no vision could be restored, in the other two cases vision of 10/20 and 5/20 was achieved for months. Stable implantation for 6 to 42 months was achieved. 2 keratoprostheses were replaced in case of endophthalmitis, 2 others were replaced by corneal grafts after 24 and 42 months. All implantation sites showed conjunctival retraction with exposure of the outer textile structure. Fibrovascular growth within the textile structure was perfect. Pressure control was possible in all cases by special Schiotz tonometry.

Conclusions: : We give proof of stable implantation with this concept of keratoprostheses is achieved. Conjunctival retraction was origin of exposure of the textile mesh with endopthalmitis in two cases. Thus modification of outer mesh is necessary to continue this successful concept.

Clinical Trial: : Regierungspräsidium Köln, Reg No: 24.33.12.1/02

Keywords: keratoprostheses • vitreoretinal surgery 
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