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Recruiting NCT07325162

NCT07325162 Development of Optical Biometer

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Clinical Trial Summary
NCT ID NCT07325162
Status Recruiting
Phase
Sponsor Cassini Technologies
Condition Cataract and IOL Surgery
Study Type INTERVENTIONAL
Enrollment 100 participants
Start Date 2025-11-07
Primary Completion 2026-02-28

Trial Parameters

Condition Cataract and IOL Surgery
Sponsor Cassini Technologies
Study Type INTERVENTIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-11-07
Completion 2026-02-28
Interventions
New Investigational Optical Biometer (Device)Comparator Device A (Cassini Ambient)omparator Device B (Argos)

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Brief 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

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.

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