Clinical trial NCT04112472: Clinical Trial ES 900 - 2019
Official title: Clinical Trial - ES 900 - 2019
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optical Biometry of the Human Eye
General Analysis of the Anterior Chamber of the Human Eye
Lead sponsor: Haag-Streit AG
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Basel, Switzerland
First posted: 2019-10-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Keratometry Measurand: Kmean (Spherical refractive power of central cornea) in keratometric diopters [dpt]
timeFrame: Through study completion, approximately 7 months.
measure: Keratometry Measurand: AST (Anterior central corneal astigmatism) in [dpt]
timeFrame: Through study completion, approximately 7 months.
measure: Keratometry Measurand: Axis (Anterior steep meridian angle) in [°]
timeFrame: Through study completion, approximately 7 months.
measure: Axial Measurand: AL (Axial length) in [mm]
timeFrame: Through study completion, approximately 7 months.
measure: Axial Measurand: CCT (Corneal thickness) in [μm]
timeFrame: Through study completion, approximately 7 months.
measure: Axial Measurand: ACD (Anterior chamber depth) in [mm]
timeFrame: Through study completion, approximately 7 months.
measure: Axial Measurand: LT (Lens thickness) in [mm]
timeFrame: Through study completion, approximately 7 months.
measure: Imaging Measurand: WTW (White-to-White) in [mm]
timeFrame: Through study completion, approximately 7 months.
measure: Imaging Measurand: ICX / ICY (Iris barycenter in horizontal direction / in vertical direction) in [mm]
timeFrame: Through study completion, approximately 7 months.
measure: Imaging Measurand: PD (Pupil diameter) in [mm]
timeFrame: Through study completion, approximately 7 months.
measure: Imaging Measurand: PCX / PCY (Pupil barycenter in horizontal direction / in vertical direction) in [mm]
timeFrame: Through study completion, approximately 7 months.
measure: Anterior corneal topography: Elevation (Anterior torical elevation) in [µm] (2D-map)
timeFrame: Through study completion, approximately 7 months.
measure: Anterior corneal topography: Axial curvature (Anterior tangential curvature) in [dpt] (2D-map)
timeFrame: Through study completion, approximately 7 months.
measure: Posterior corneal topography: Elevation (Posterior torical elevation) in [µm] (2D-map)
timeFrame: Through study completion, approximately 7 months.
measure: Posterior corneal topography: Axial curvature (Posterior tangential curvature) in [dpt] (2D-map)
timeFrame: Through study completion, approximately 7 months.
measure: Corneal pachymetry: Corneal thickness map in [µm]
timeFrame: Through study completion, approximately 7 months.
measure: Simulated Keratometry: SimKmean (Mean simulated keratometry) in [dpt]
timeFrame: Through study completion, approximately 7 months.
measure: Simulated Keratometry: SimAST (Simulated astigmatism) in [dpt]
timeFrame: Through study completion, approximately 7 months.
measure: Simulated Keratometry: SimAxis (Simulated keratometry anterior steep meridian angle) in [°]
timeFrame: Through study completion, approximately 7 months.
measure: Simulated Keratometry: Anterior corneal shape factor (E): Dimensionless quantity
timeFrame: Through study completion, approximately 7 months.
measure: Simulated Posterior Keratometry: SimPKmean (Mean simulated posterior keratometry) in [dpt]
timeFrame: Through study completion, approximately 7 months.
measure: Simulated Posterior Keratometry: SimPAST (Simulated keratometry posterior corneal astigmatism) in [dpt]
timeFrame: Through study completion, approximately 7 months.
measure: Simulated Posterior Keratometry: SimPAxis (Simulated keratometry posterior steep meridian angle) in [°]
timeFrame: Through study completion, approximately 7 months.
measure: Simulated Posterior Keratometry: Posterior corneal shape factor (PE): Dimensionless quantity
timeFrame: Through study completion, approximately 7 months.
Secondary outcomes:
Other outcomes:
measure: Acquisition of volumetric OCT Data of the eye.
timeFrame: Through study completion, approximately 7 months
measure: Acquisition of photographic images of the eye.
timeFrame: Through study completion, approximately 7 months
Locations:
city: Basel
country: Switzerland
facility: University Hopital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: David Goldblum, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: