Background. None of the keratoprostheses available today is absolutely succ
essful in the long term, neither the problems of extrusion, retroprosthetic
membrane formation and intraocular pressure rise are yet solved. A new typ
e of keratoprosthesis is required which can show improved ingrowth characte
ristics and allow Intraocular pressure measurements. In order to possibly m
eet the above mentioned requirements we developed a flexible silicone kerat
oprosthesis with scleral fixation and chemical surface modification.
Methods. The one-piece keratoprosthesis is made of silicone rubber. Its opt
ical zone has a diameter of 11 mm and is 0.3 mm thick. The surface-modified
haptic consists of a scleral rim and eight branches for scleral fixation.
A ridge at the back of the keratoprosthesis fitting into the trephination h
ole shall avoid leakage and retroprosthetic membrane formation. Optical and
mechanical qualities are characterised by tensile tests, spectrophotometry
and topography.
Results. A method for keratoprosthesis-production was established. The opti
cal quality of the device was improved by submicron lathing of the mould. S
pectrophotometry showed high visible and ultraviolet light transmission of
the silicone. Mechanical tests with silicone samples revealed high tensile
strength and elongation at break. The mechanical properties were not impair
ed by surface modification.
Conclusions. The production of a flexible silicone keratoprosthesis with hi
gh optical and mechanical properties was established. Its use both for the
treatment of permanently opacified corneas and as temporary keratoprosthesi
s seems to be possible.