Device Dossier
Anterior eye segment analysis system
Device Dossier for Anterior eye segment analysis system (Anterior eye segment analysis system, Class IIa, sponsor Kevin Grundy (IBD)). ARTG record,…
- GMDN category: Anterior eye segment analysis system
Intended purpose
The GALILEI is designed to take images of the anterior segment of the eye, which includes cornea, iris, pupil, anterior chamber, and crystalline lens. To evaluate: • Corneal shape • Pachymetry (corneal thickness) • Position of the cornea relative to iris and lens • Corneal and lenticular opacity • Condition of the ocular surface • Anterior chamber angle • Anterior chamber depth • Volume of the anterior chamber • White-to-white distance • Pupil size • Condition and position of implants (e.g. IOL, phakic IOLs, intracorneal rings) • Location of cataracts (nuclear, sub capsular and/or cortical), using cross slit imaging with densitometry • Condition of the lens (opaque crystalline lens) • Lens shape • Crystalline lens thickness The GALILEI G6 is designed to additionally evaluate: • Axial length The GALILEI also performs calculations to assist physicians in determining the power of an intraocular lens for implantation.