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RecruitingNot ApplicableNCT07325162

Development of Optical Biometer

Development of a Next-Generation Optical Biometer for Eyes With Cataract

Sponsor

Cassini Technologies

Enrollment

100 participants

Start Date

Nov 7, 2025

Study Type

INTERVENTIONAL

Conditions

Cataract and IOL Surgery

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

Min Age: 18 Years

Inclusion Criteria3

  • The presence of cataract in at least one eye.
  • Minimally 21 years of age.
  • Provided written informed consent.

Exclusion Criteria2

  • The inability to properly fixate on a fixation target for several seconds
  • The inability to provide informed consent.
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Interventions

DEVICENew Investigational Optical Biometer (Device)

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.

DEVICEComparator Device A (Cassini Ambient)

FDA-cleared corneal topographer used as a reference standard comparator for keratometry.

DEVICEomparator Device B (Argos)

FDA-cleared optical biometer used as a second comparator to assess agreement and measurement differences.

Locations(1)

Bishop Eye Center

Hilton Head Island, South Carolina, United States

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NCT07325162

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