Development of Optical Biometer (CH-0203)

Cassini Technologies

Status: Enrolling

Conditions: Cataract and IOL Surgery

Treatments: Device: New Investigational Optical Biometer (Device); Device: omparator Device B (Argos); Device: Comparator Device A (Cassini Ambient)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07325162

2025-0203

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

All enrolled subjects

Other group

Description:

All eligible subjects will undergo ocular biometry using three devices: 1. the investigational optical biometer, 2. Comparator Device A, and 3. Comparator Device B. Measurements from all devices will be obtained at the same visit and used only for diagnostic comparison. No treatment assignment occurs.

Treatment:

Device: Comparator Device A (Cassini Ambient)

Device: omparator Device B (Argos)

Device: New Investigational Optical Biometer (Device)