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NCT07325162NARecruiting

Development of Optical Biometer

Cassini Technologies

Start Date

11/7/2025

Completion Date

3/30/2026

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion criteria: * The presence of cataract in at least one eye. * Minimally 21 years of age. * Provided written informed consent. Exclusion criteria: * The inability to properly fixate on a fixation target for several seconds * The inability to provide informed consent.

Interventions

DEVICE

New Investigational Optical Biometer (Device)

DEVICE

Comparator Device A (Cassini Ambient)

DEVICE

omparator Device B (Argos)

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Conditions

Cataract and IOL Surgery

Locations

Bishop Eye Center

Hilton Head Island, South Carolina 29926

United States