Optical Biometer for Cataract
(CH-0203 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults over 21 years old with cataracts in at least one eye. Participants must be able to give written consent. It's designed to test a new device called the Helioscope on eyes affected by cataracts, which can impact vision and measurements needed for surgery.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Measurement
Participants undergo ocular biometry using the investigational optical biometer and comparator devices for diagnostic comparison
Follow-up
Participants are monitored for safety and effectiveness after measurements
What Are the Treatments Tested in This Trial?
Interventions
- New Investigational Optical Biometer
Trial Overview
The study tests the Helioscope, a novel optical biometer combining LED-based corneal topography and SS-OCT technology, against two existing devices (Argos and Cassini Ambient). The goal is to ensure it provides accurate ocular measurements even in eyes with dense cataracts.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
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Who Is Running the Clinical Trial?
Cassini Technologies
Lead Sponsor
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