Cataract and IOL Surgery
Conditions
Keywords
Optical Biometer, SS-OCT
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.
Interventions
DEVICENew 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.
DEVICEComparator Device A (Cassini Ambient)
FDA-cleared corneal topographer used as a reference standard comparator for keratometry.
DEVICEomparator Device B (Argos)
FDA-cleared optical biometer used as a second comparator to assess agreement and measurement differences.
Sponsors
Cassini Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular parameters of cataractous eyes measured with a novel biometer | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Ocular biometric values (axial length, anterior chamber depth, keratometry, limbal white to white, lens thickness, and central corneal thickness - measured in millimetres) measured by the Helioscope device will be compared against the same values captured by the Argos biometer and Ambient topographer devices (both FDA approved devices on label use) in 200 eyes. |
Countries
United States
Contacts
Primary ContactDr. Michael Petrik Petrik, OD
Outcome results
None listed