Development of Optical Biometer

Part of paid clinical trials in Hilton Head Island, South Carolina.

Sponsor
Cassini Technologies
Study ID
NCT07325162
Status
Recruiting
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Conditions

  • Cataract and IOL Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Comparator Device A (Cassini Ambient) — DEVICE
    FDA-cleared corneal topographer used as a reference standard comparator for keratometry.
  • omparator Device B (Argos) — DEVICE
    FDA-cleared optical biometer used as a second comparator to assess agreement and measurement differences.

Study Details

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.

Key Dates

Start date
Nov 7, 2025
Status verified
Jan 2026
Primary completion
Feb 28, 2026
Completion
Mar 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Bishop Eye CenterHilton Head IslandSouth Carolina29926
Paul Bell Bell, MD
[email protected]
843-689-3937

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Bishop Eye Center· Hilton Head Island, SC

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