General Analysis of the Anterior Chamber of the Human Eye, Optical Biometry of the Human Eye
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DEVICEEYESTAR 900
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.
Sponsors
Haag-Streit AG
University Hospital, Basel, Switzerland
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
Yes
Inclusion criteria
* 18 years or older; * volunteers with phakic eyes, no cataract surgery indicated and with existing vitreous; * patients seeking cataract surgery; * patients with pseudophakic eye; * patients with oil-filled eye; * patients with aphakic eye.
Exclusion criteria
* underage patients (younger than 18 years); * vulnerable patients; * inability to give informed consent; * inability to maintain stable fixation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Keratometry-Measurands | Through study completion, approximately 9 months. | In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for K1, K2 (R1, R2, AST) in \[dpt\]; Axis in \[°\]. |
| Axial measurands | Through study completion, approximately 9 months | 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 \[mm\]. |
| Imaging | Through study completion, approximately 9 months | 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 \[mm\]. |
| Anterior corneal topography | Through study completion, approximately 9 months | In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for elevation in \[µm \]; axial curvature in \[dpt\]. |
| Posterior corneal topography | Through study completion, approximately 9 months | In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for elevation in \[µm\]; axial curvature in \[dpt\]. |
| Corneal pachymetry | Through study completion, approximately 9 months | In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for CT in \[µm \]. |
| Posterior corneal keratometry | Through study completion, approximately 9 months | In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for PK1, PK2 (PR1, PR2, PAST) in \[dpt\]; PAxis in \[°\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aquisition of volumetric OCT Data of the eye. | Through study completion, approximately 9 months | Data is collected, but not processed within the scope of this clinical trial. |
| Aquisition of photographic images of the eye. | Through study completion, approximately 9 months | Data is collected, but not processed within the scope of this clinical trial. |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORDavid Goldblum, Prof. Dr.
University Hospital, Basel, Switzerland
Outcome results
None listed