The Helioscope (Cassini Technologies B.V.) is a novel device under development that aims at combining LED-based corneal topography and SS-OCT to provide accurate and fast measurements of both the corneal shape and the ocular biometry. To that end, the hardware and software of the Cassini color-LED topographer (Cassini Technologies B.V.) is combined with a novel SS-OCT device. While the new Helioscope can largely be evaluated using data acquired with healthy eyes, one of its main use-cases is providing input for IOL power formulae for cataract surgery. Thus, it is essential that the device can perform measurements in eyes with (dense) cataract. As cataract changes the optical properties of the crystalline lens and the OCT measurement is optical, this is not a given. This study therefore seeks a dataset of Helioscope measurements performed in eyes with cataract that can be used to develop the software algorithms of the Helioscope.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
Investigational optical biometer used to obtain axial length, keratometry, anterior chamber depth, lens thickness, and total corneal astigmatism. Device is being evaluated for measurement accuracy and agreement.
FDA-cleared corneal topographer used as a reference standard comparator for keratometry.
FDA-cleared optical biometer used as a second comparator to assess agreement and measurement differences.
Bishop Eye Center
Hilton Head Island, South Carolina, United States
RECRUITINGOcular parameters of cataractous eyes measured with a novel biometer
Primary endpoint: Biometric ocular parameters of axial length, anterior chamber depth, central corneal thickness, keratometry, lens thickness and limbal white to white will be measured by the Helioscope device in 200 eyes.
Time frame: Overall study to complete up to 12 months
Comparison of ocular biometry measured by a novel biometer against FDA approved devices for planning cataract surgery
Ocular biometric values (axial length, anterior chamber depth, keratometry, limbal white to white, lens thickness, and central corneal thickness - measured in millimetres) measured by the Helioscope device will be compared against the same values captured by the Argos biometer and Ambient topographer devices (both FDA approved devices on label use) in 200 eyes.
Time frame: Overall study to complete up to 12 months
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