Development of a Next-Generation Optical Biometer for Eyes With Cataract
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Ocular parameters of cataractous eyes measured with a novel biometer
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
All enrolled subjects
All eligible subjects will undergo ocular biometry using three devices:
- the investigational optical biometer,
- Comparator Device A, and
- Comparator Device B. Measurements from all devices will be obtained at the same visit and used only for diagnostic comparison. No treatment assignment occurs.
Intervention: New Investigational Optical Biometer (Device) (Device)
All enrolled subjects
All eligible subjects will undergo ocular biometry using three devices:
- the investigational optical biometer,
- Comparator Device A, and
- Comparator Device B. Measurements from all devices will be obtained at the same visit and used only for diagnostic comparison. No treatment assignment occurs.
Intervention: Comparator Device A (Cassini Ambient) (Device)
All enrolled subjects
All eligible subjects will undergo ocular biometry using three devices:
- the investigational optical biometer,
- Comparator Device A, and
- Comparator Device B. Measurements from all devices will be obtained at the same visit and used only for diagnostic comparison. No treatment assignment occurs.
Intervention: omparator Device B (Argos) (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Comparison of ocular biometry measured by a novel biometer against FDA approved devices for planning cataract surgery(Overall study to complete up to 12 months)