Cataract Clinical Trial
Official title:
GALILEI G6 Lens Professional vs. a Predicate Device: a Comparison Study
The purpose of this study is to compare the Ziemer Ophthalmic Systems AG GALILEI G6 Lens Professional to the Oculus Pentacam® AXL for taking images and measurements of the anterior segment of the eye, including the cornea, pupil, anterior chamber and lens, to assist in determining the power of the intraocular lens for implantation.
A corneal topographer/biometer named GALILEI G6 Lens Professional was developed by Ziemer
Ophthalmic Systems AG for the measurement of anterior segment geometry and axial intraocular
distances. The measurement principle of the corneal topographer corresponds to that of the
commercially available Galilei G4 Dual Scheimpflug Analyzer, whereas the measurement
principle of the biometer is based on low coherence interferometry/reflectometry, which has
been widely used and applied clinically by a number of predicate devices.
One complete measurement consists of a corneal topography/ tomography scan followed by three
consecutive, axial biometry scans of the anterior segment (cornea and crystalline lens) and
three consecutive, axial biometry scans of the retina. The measurement process is continuous
but divided into three alignment-click-steps.
Such measurements can be applied to given Intra Ocular Lens (IOL) types and IOL equations, to
permit the calculation of recommended IOLs to be implanted during cataract surgery in order
to achieve the desired vision correction.
The primary objectives of this clinical study are to: 1) evaluate the inter-device
repeatability, inter-operator repeatability and reproducibility of the GALILEI G6 Lens
Professional in repeated measurements of anterior segment geometry and axial intraocular
distances and, 2) demonstrate substantial equivalence through examining agreement of the
GALILEI measurements to those of the predicate device, the Pentacam® AXL.
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