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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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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.
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.
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.
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: 18.104.22.168/02
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