FDA allows trial expansion for Sunrise's LTK system:
This article was originally published in Clinica
Executive Summary
Sunrise Technologies has received conditional approval from the US FDA to replace its Sun 1000 holmium laser system with its new Hyperion laser thermal keratoplasty system at all of its clinical investigation sites in the US. The approval will allow the new device to be tested in a current trial as a treatment for hyperopia ranging from +1.25 to +5.625 dioptres. The system was recommended for approval by an FDA advisory panel earlier this year for the temporary reduction of low to moderate hyperopia in the range of +0.75 to +2.50 dioptres (see Clinica 892, p 21).