Development of Optical Biometer

NCT07325162 | Recruiting FDA Device

• 1 other identifier: 2025-0203
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Optical Biometer; SS-OCT

Outcome Measures

Primary Outcomes (1)

• Ocular parameters of cataractous eyes measured with a novel biometer

  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.

  Overall study to complete up to 12 months

Secondary Outcomes (1)

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

  Overall study to complete up to 12 months

Study Arms (1)

All enrolled subjects

OTHER

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.

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

Interventions

Comparator Device A (Cassini Ambient) DEVICE

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

All enrolled subjects

omparator Device B (Argos) DEVICE

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

All enrolled subjects

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.

All enrolled subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cassini Technologies: lead

Study Sites (1)

Bishop Eye Center

Hilton Head Island, South Carolina, 29926, United States

RECRUITING

Related Publications (1)

• Hashemi H, Sardari S, Yekta A, Khabazkhoob M. The repeatability and agreement of biometric measurements by dual Scheimpflug device with integrated optical biometer. Sci Rep. 2022 May 11;12(1):7748. doi: 10.1038/s41598-022-11953-8.

  PMID: 35546610 RESULT

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Dr. Michael Petrik Petrik, OD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: January 8, 2026
• Study Start: November 7, 2025
• Primary Completion: February 28, 2026
• Study Completion: March 30, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)