NCT07325162

Development of Optical Biometer

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Cassini Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-07
• Primary completion: 2026-02-28
• Completion: 2026-03-30
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study