Development of Optical Biometer (CH-0203)

January 6, 2026 updated by: Cassini Technologies

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • South Carolina
      • Hilton Head Island, South Carolina, United States, 29926
        • Recruiting
        • Bishop Eye Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Overall study to complete up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Overall study to complete up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cassini Technologies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2025

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-0203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared because, although the data are randomized, they are being used to develop and validate proprietary software algorithms for the investigational device.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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