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| Name | Class |
|---|---|
| University Hospital, Basel, Switzerland | OTHER |
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The primary objective of this clinical trial is to assess the clinical performance of the investigational device. To that end, for each measure and the in-vivo repeatability will be quantified, as well as the mean measurement deviation with respect to the current gold standard device. As a secondary objective of the study, raw measurement data will be collected, to allow for improvements of existing algorithms, development of additional measure and and for retrospective analysis.
EYESTAR 900 (the investigational device) is a new device by HAAG-STREIT AG, for measurement of optical biometry and advanced corneal topography by swept-source optical coherence tomography (OCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Examination of participants | Experimental | Examination of participants by means of the investigational device, Eyestar 900 as well as the comparative devices. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EYESTAR 900 | Device | EYESTAR 900 is an optical biometry device used to create a geometrical representation of the eye by means of optical interferometry. The experimental intervention is an optical, non-contact examination with the investigational device EYESTAR 900. |
| Measure | Description | Time Frame |
|---|---|---|
| Keratometry-Measurands | In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for K1, K2 (R1, R2, AST) in [dpt]; Axis in [°]. | Through study completion, approximately 9 months. |
| Axial measurands | In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for CCT in [µm]; AD in [mm]; ACD in [mm]; LT in [mm]; AL in [mm]. | Through study completion, approximately 9 months |
| Imaging | In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for WTW in [mm]; ICX, ICY in [mm]; PD in [mm]; PCX, PCY in [mm]. | Through study completion, approximately 9 months |
| Anterior corneal topography | In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for elevation in [µm ]; axial curvature in [dpt]. | Through study completion, approximately 9 months |
| Posterior corneal topography | In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for elevation in [µm]; axial curvature in [dpt]. | Through study completion, approximately 9 months |
| Corneal pachymetry | In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for CT in [µm ]. | Through study completion, approximately 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Aquisition of volumetric OCT Data of the eye. | Data is collected, but not processed within the scope of this clinical trial. | Through study completion, approximately 9 months |
| Aquisition of photographic images of the eye. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Goldblum, Prof. Dr. | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | 4056 | Switzerland |
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| Posterior corneal keratometry | In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for PK1, PK2 (PR1, PR2, PAST) in [dpt]; PAxis in [°]. | Through study completion, approximately 9 months |
Data is collected, but not processed within the scope of this clinical trial.
| Through study completion, approximately 9 months |