Clinical Trial ES 900 - 2019

General Analysis of the Anterior Chamber of the Human Eye Clinical Trial

Official title:

Clinical Trial - ES 900 - 2019

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04112472
• Other study ID #: 1023551
• Status: Completed
• Phase: N/A
• Start date: July 11, 2019
• Est. completion date: September 1, 2019

Study information

• Verified date: November 2019
• Source: Haag-Streit AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this clinical trial is to assess the clinical performance of the investigational device. To that end, the Limits of Agreement with respect to comparator devices are analyzed. The Limits of Agreement allow estimating the expected measurement deviation per measurand, which is compared to the "maximum acceptable measurement error", as defined by the Risk Analysis of the investigational device, to assess the risk involved in measurements of the investigational device. Furthermore, the in-vivo repeatability will be quantified for each measurand, as well as the confidence intervals for mean 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 improvement of existing algorithms, development of additional measurands and for retrospective analysis.

Description:

The EYESTAR900 (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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

At least one eye of each subject needs to fulfill one of the following inclusion criteria:

• volunteers with normal phakic eye;

• patients seeking cataract surgery;

• patients with pseudophakic eye;

• patients with oil-filled eye;

• patients with aphakic eye.

Exclusion Criteria:

• Exclusion criteria per subject:

• underage patients (younger than 18 years);

• vulnerable patients;

• inability to give informed consent;

• Exclusion criteria per eye:

• inability to maintain stable fixation;

• corneal lesions or scarring;

• previous corneal surgery (except: pseudophakic eyes, oil-filled eyes, aphakic eyes);

• previous intraocular surgery (except: pseudophakic eyes, oil-filled eyes, aphakic eyes);

• active inflammation of the eye;

• active infection of the eye;

• tear film break up time of less than 5 sec.

Related Conditions & MeSH terms

• General Analysis of the Anterior Chamber of the Human Eye
• Optical Biometry of the Human Eye

Intervention

Device:
• EYESTAR 900
EYESTAR 900 is an optical biometry device used to create a geometrical representation of the eye by means of optical interferometry. The intervention are optical, non-contact examinations with the investigational device EYESTAR 900 and comparative device(s). Results of the examinations serve to compare the performance data of the investigational device with those of the comparative devices.

Locations

Country	Name	City	State
Switzerland	University Hopital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
Haag-Streit AG	University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acquisition of volumetric OCT Data of the eye.	The data is collected to allow for: Improvement of existing algorithms, development of additional measurands and for retrospective analysis. The data will not be processed within the scope of this clinical trial.	Through study completion, approximately 7 months
Other	Acquisition of photographic images of the eye.	The data is collected to allow for: Improvement of existing algorithms, development of additional measurands and for retrospective analysis. The data will not be processed within the scope of this clinical trial.	Through study completion, approximately 7 months
Primary	Keratometry Measurand: Kmean (Spherical refractive power of central cornea) in keratometric diopters [dpt]	In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for Kmean.	Through study completion, approximately 7 months.
Primary	Keratometry Measurand: AST (Anterior central corneal astigmatism) in [dpt]	In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for AST.	Through study completion, approximately 7 months.
Primary	Keratometry Measurand: Axis (Anterior steep meridian angle) in [°]	In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for Axis. Axis is the angle of the anterior central corneal astigmatism.; The value of Axis is measured in [°], whereas the differences shall be expressed in [dpt].	Through study completion, approximately 7 months.
Primary	Axial Measurand: AL (Axial length) in [mm]	In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for AL. AL is measured from the corneal tear film to the inner limiting membrane.	Through study completion, approximately 7 months.
Primary	Axial Measurand: CCT (Corneal thickness) in [µm]	In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for CCT. CCT is measured from the corneal tear film to the corneal endothelium.	Through study completion, approximately 7 months.
Primary	Axial Measurand: ACD (Anterior chamber depth) in [mm]	In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for ACD. ACD is measured from the corneal tear film to the anterior surface of the lens.	Through study completion, approximately 7 months.
Primary	Axial Measurand: LT (Lens thickness) in [mm]	In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for LT. LT is measured from the anterior to the posterior surface of the lens.	Through study completion, approximately 7 months.
Primary	Imaging Measurand: WTW (White-to-White) in [mm]	In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator devices for WTW. WTW distance is the horizontal diameter of a best fit circle to the iris border.	Through study completion, approximately 7 months.
Primary	Imaging Measurand: ICX / ICY (Iris barycenter in horizontal direction / in vertical direction) in [mm]	In-vivo repeatability of investigational and comparator device for Iris barycenter. The iris barycenter is the displacement of the iris center relative to the vertex in X (horizontal direction) and Y (vertical direction) coordinates.	Through study completion, approximately 7 months.
Primary	Imaging Measurand: PD (Pupil diameter) in [mm]	In-vivo repeatability of investigational and comparator device for PD. PD is measured at the diameter of a best fit circle to the pupil border.	Through study completion, approximately 7 months.
Primary	Imaging Measurand: PCX / PCY (Pupil barycenter in horizontal direction / in vertical direction) in [mm]	In-vivo repeatability of investigational and comparator device for Iris barycenter. The pupil barycenter is the displacement of the iris center relative to the vertex in X (horizontal direction) and Y (vertical direction) coordinates.	Through study completion, approximately 7 months.
Primary	Anterior corneal topography: Elevation (Anterior torical elevation) in [µm] (2D-map)	In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for elevation in [µ]; axial curvature in [dpt].	Through study completion, approximately 7 months.
Primary	Anterior corneal topography: Axial curvature (Anterior tangential curvature) in [dpt] (2D-map)	In-vivo repeatability and confidence interval of difference between investigational and comparator devices for Anterior torical elevation. The measuring performance over the 2D-map is subdivided in three zones (central zone, middle zone, peripheral zone).	Through study completion, approximately 7 months.
Primary	Posterior corneal topography: Elevation (Posterior torical elevation) in [µm] (2D-map)	In-vivo repeatability of investigational and comparator device for Posterior torical elevation. The measuring performance over the 2D-map is subdivided in three zones (central zone, middle zone, peripheral zone).	Through study completion, approximately 7 months.
Primary	Posterior corneal topography: Axial curvature (Posterior tangential curvature) in [dpt] (2D-map)	In-vivo repeatability and confidence interval of differences of investigational and comparator devices for Posterior tangential curvature. The measuring performance over the 2D-map is subdivided in three zones (central zone, middle zone, peripheral zone).	Through study completion, approximately 7 months.
Primary	Corneal pachymetry: Corneal thickness map in [µm]	In-vivo repeatability and confidence interval of differences of investigational and comparator device for Corneal thickness map. The measuring performance over the 2D-map is subdivided in three zones (central zone, middle zone, peripheral zone).	Through study completion, approximately 7 months.
Primary	Simulated Keratometry: SimKmean (Mean simulated keratometry) in [dpt]	In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator devices for SimKmean.	Through study completion, approximately 7 months.
Primary	Simulated Keratometry: SimAST (Simulated astigmatism) in [dpt]	In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator devices for SimAST.	Through study completion, approximately 7 months.
Primary	Simulated Keratometry: SimAxis (Simulated keratometry anterior steep meridian angle) in [°]	In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for SimAxis. The value of Axis is measured in [°], whereas the differences shall be expressed in [dpt]. SimAxis is the angle of the larger simulated keratometry radius with respect to the horizontal axis X.	Through study completion, approximately 7 months.
Primary	Simulated Keratometry: Anterior corneal shape factor (E): Dimensionless quantity	In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for Anterior corneal shape factor (E), that characterizes the anterior corneal asphericity.	Through study completion, approximately 7 months.
Primary	Simulated Posterior Keratometry: SimPKmean (Mean simulated posterior keratometry) in [dpt]	In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for SimPKmean. SimPKmean is the corresponding refractive power in diopters.	Through study completion, approximately 7 months.
Primary	Simulated Posterior Keratometry: SimPAST (Simulated keratometry posterior corneal astigmatism) in [dpt]	In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for SimPAST.	Through study completion, approximately 7 months.
Primary	Simulated Posterior Keratometry: SimPAxis (Simulated keratometry posterior steep meridian angle) in [°]	In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for SimPAxis. SimPAxis represents the angle of the larger simulated keratometry radius of curvature with respect to the horizontal axis X.	Through study completion, approximately 7 months.
Primary	Simulated Posterior Keratometry: Posterior corneal shape factor (PE): Dimensionless quantity	In-vivo repeatability, limits of agreement and confidence interval of difference between investigational and comparator device for Posterior corneal shape factor (PE), that characterizes the posterior corneal asphericity.	Through study completion, approximately 7 months.