Konan’s clinical trial program gives medical device companies full access to the latest, 510(k) cleared specular microscopes without the headaches associated with equipment ownership, such as transportation, storage, calibration, maintenance, etc.

Installation, calibration, training and servicing are done correctly, consistently and verifiably, and are fully documented.

Konan specular microscopes are well established as core supportive science through a host of FDA device and drug trials, including being used as the standard platform for most professional reading centers.  A presentation by Dr. Edelhauser can be reviewed by selecting the image below on the left.

Konan specular microscopes are the only devices cleared under FDA 510(k) category "Specular Microscopes - NQE" (select second image below for FDA Listing information).  FDA guidance documents for Phakic IOLs/ ICL require specular microscopy and strongly suggest the Center Method analysis for clinical trials;  additionally all such approved devices include labeling requirements for clinicians to assess the corneal endotholium (select third lower lower image).  Drs. McCarey and Edelhauser et.al also provide a landmark review of specular microscopy for FDA clinical trials in the January 2008 publication of Cornea (referenced below on the right).  The standards defined were all developed on Konan specular microscopes and are only specifically applicable to the same devices.