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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All enrolled subjects | Other | All eligible subjects will undergo ocular biometry using three devices:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular parameters of cataractous eyes measured with a novel biometer | 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. | Overall study to complete up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of ocular biometry measured by a novel biometer against FDA approved devices for planning cataract surgery | 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Petrik Petrik, OD | Contact | 236-982-8672 | m.petrik@cassini-technologies.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bishop Eye Center | Recruiting | Hilton Head Island | South Carolina | 29926 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35546610 | Result | Hashemi H, Sardari S, Yekta A, Khabazkhoob M. The repeatability and agreement of biometric measurements by dual Scheimpflug device with integrated optical biometer. Sci Rep. 2022 May 11;12(1):7748. doi: 10.1038/s41598-022-11953-8. |
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IPD will not be shared because, although the data are randomized, they are being used to develop and validate proprietary software algorithms for the investigational device.
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Comparator Device A (Cassini Ambient) | Device | FDA-cleared corneal topographer used as a reference standard comparator for keratometry. |
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| omparator Device B (Argos) | Device | FDA-cleared optical biometer used as a second comparator to assess agreement and measurement differences. |
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| Overall study to complete up to 12 months |