Recruiting

Helioscope

Sponsor:

Cassini Technologies

Code:

NCT07325162

Conditions

Cataract and IOL Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

New Investigational Optical Biometer (Device)

Comparator Device A (Cassini Ambient)

omparator Device B (Argos)

Study Details

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.

Conditions

Cataract and IOL Surgery

Study ID

NCT07325162

Start date

Nov 7, 2025

Status verified date

Jan, 2026

Completion date

Mar 30, 2026

Anticipated

Primary completion date

Feb 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: All enrolled subjects

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.

Interventions

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.

Comparator Device A (Cassini Ambient)

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

omparator Device B (Argos)

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

Primary outcome measure

  • Ocular parameters of cataractous eyes measured with a novel biometer [ Time Frame: Overall study to complete up to 12 months ]

Central Contacts and Locations

Central contacts

Dr. Michael Petrik Petrik, OD

236-982-8672m.petrik@cassini-technologies.com

Locations

Bishop Eye Center

Recruiting

Hilton Head Island, South Carolina, United States, 29926

Contacts

Paul Bell Bell, MD

843-689-3937paulmbell@gmail.com

More Information

Sponsor

Cassini Technologies

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Keywords

  • Optical Biometer
  • SS-OCT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Cassini Technologies on 2026-01-08.