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RECRUITING
NCT07325162
NA

Development of Optical Biometer

Sponsor: Cassini Technologies

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-11-07

Completion Date

2026-03-30

Last Updated

2026-01-08

Healthy Volunteers

No

Interventions

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.

Locations (1)

Bishop Eye Center

Hilton Head Island, South Carolina, United States