Clinical Trial ES 900 - 2019

Clinical Trial - ES 900 - 2019

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.

Study Overview

• Status: Completed
• Conditions: Optical Biometry of the Human Eye; General Analysis of the Anterior Chamber of the Human Eye
• Intervention / Treatment: Device: EYESTAR 900

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4056
    • University Hopital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Examination of participants; Examination of participants by means of the investigational device as well as the comparative devices.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Haag-Streit AG
• Collaborators: University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2019
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1023551

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No