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NCT Number: NCT07325162

Development of Optical Biometer

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.

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Key information

Conditions

Cataract and IOL Surgery Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bishop Eye Center

Hilton Head Island, South Carolina, 29926, United States

Location status: Recruiting

Location contact

Paul Bell Bell, MD

CONTACT

[email protected]

843-689-3937

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

New Investigational Optical Biometer (Device)

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.

Comparator Device A (Cassini Ambient)

Device

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

omparator Device B (Argos)

Device

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

Primary outcomes

  1. Ocular parameters of cataractous eyes measured with a novel biometer

    Time frame: Overall study to complete up to 12 months

    Primary endpoint:

    Biometric ocular parameters of axial length, anterior chamber depth, central corneal thickness, keratometry, lens thickness and limbal white to white will be measured by the Helioscope device in 200 eyes.

Secondary outcomes

  1. Comparison of ocular biometry measured by a novel biometer against FDA approved devices for planning cataract surgery

    Time frame: Overall study to complete up to 12 months

    Ocular biometric values (axial length, anterior chamber depth, keratometry, limbal white to white, lens thickness, and central corneal thickness - measured in millimetres) measured by the Helioscope device will be compared against the same values captured by the Argos biometer and Ambient topographer devices (both FDA approved devices on label use) in 200 eyes.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Michael Petrik Petrik, OD

CONTACT

[email protected]

236-982-8672

Sponsors and collaborators

Lead sponsor

Cassini Technologies

Industry

Registry information

Official study title

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

Acronym: CH-0203

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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