Device Dossier
Anterior eye segment analysis system
Device Dossier for Anterior eye segment analysis system (Anterior eye segment analysis system, Class IIa, sponsor EYETEK). ARTG record, intended purpose,…
- GMDN category: Anterior eye segment analysis system
Intended purpose
Diagnostic ophthalmic device intended to be used by eye specialists in ophthalmological diagnosis to perform the analysis of the anterior segment of the eye. The device combines corneal topograpgy with Placido's disk and OCT-based anterier segment tomograpgy and is disigned for the screening, the capture and the processing of 25 clear section images, in high resolution over a diameter of 16 mm: providing pachymetry data, elecation , curvature and pwer information of both corneal surfaces. Additional satellite exams allow an accurate pupil diameter measurement in scotopic, mesopic, phototopic conditions and in dynamic mode and the integration with corneal map. On the basis of the pachmetry map and corneal elevation data, the device allows the intrastromal rings system planning, for the correction of refractive defects and some forms of keratoconus. The device allows the glaucoma screening and gives the measurement of iridocorneal angles and pachymetry. These values, and the most common IOP correction formulas are useful to diagnose some diseases which can be due to the conformation of the anterior chamber.