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RECRUITINGINTERVENTIONAL

Development of Optical Biometer

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - The presence of cataract in at least one eye. - Minimally 21 years of age. - Provided written willing to sign a consent form. Who Should NOT Join This Trial: - The inability to properly fixate on a fixation target for several seconds - The inability to provide willing to sign a consent form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

New 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.

DEVICE

Comparator Device A (Cassini Ambient)

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

DEVICE

omparator 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