Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Study - ES 900 - 2020-2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04392349
Recruitment Status : Completed
First Posted : May 18, 2020
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Haag-Streit AG

Brief Summary:

The EYESTAR 900 with software version i9.5.1.0 includes new analysis functionality. Since its clinical performance cannot be assessed based solely on clinical literature as found in the Clinical Evaluation Report, further data from a clinical trial is required. The objective of this trial is to assess the clinical performance of the new features of the EYESTAR 900 with software version i9.5.1.0.

This study is a necessary part of the clinical evaluation process of the investigational device. The results of this study are used for the clinical evaluation, and for reporting of in-vivo repeatabilities in the instructions for use of the investigational device, as required by topography standards.


Condition or disease Intervention/treatment Phase
Cataract Keratoconus Device: Haag-Streit EYESTAR 900 Device: Tomey CASIA 2 Device: Oculus PENTACAM HR Device: Zeiss ATLAS 9000 Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Study - ES 900 - 2020-2
Actual Study Start Date : July 1, 2020
Actual Primary Completion Date : August 20, 2020
Actual Study Completion Date : December 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
NORMAL
Normal group includes eyes with healthy cornea.
Device: Haag-Streit EYESTAR 900
The EYESTAR 900 is a new device developed by HAAG-STREIT AG which utilises Optical Coherence Tomography (OCT) for quantitative measurements of the geometry of the eye. As a successor to the LENSTAR 900, it represents the most recent in a series of successful biometry devices.

Device: Tomey CASIA 2
The CASIA2 is a testing application for Cataract / Glaucoma / Cornea Surgery already established on the market. It is a representative device for measurement of anterior and posterior corneal curvature (anterior and posterior corneal topography) by optical coherence tomography, and for measurement of crystalline lens tilt by optical coherence tomography.

Device: Oculus PENTACAM HR
The Pentacam HR is a high-resolution rotating Scheimpflug camera system for anterior segment analysis already established on the market. It is used as representative device for advanced anterior segment analysis such as anterior and posterior corneal topography and corneal pachymetry.

Device: Zeiss ATLAS 9000
ATLAS is a corneal topography system used as representative device for measurement of anterior corneal curvature (anterior corneal topography).

IRREGULAR
Irregular goup includes eyes with irregular astigmatism or corneal scarring.
Device: Haag-Streit EYESTAR 900
The EYESTAR 900 is a new device developed by HAAG-STREIT AG which utilises Optical Coherence Tomography (OCT) for quantitative measurements of the geometry of the eye. As a successor to the LENSTAR 900, it represents the most recent in a series of successful biometry devices.

Device: Tomey CASIA 2
The CASIA2 is a testing application for Cataract / Glaucoma / Cornea Surgery already established on the market. It is a representative device for measurement of anterior and posterior corneal curvature (anterior and posterior corneal topography) by optical coherence tomography, and for measurement of crystalline lens tilt by optical coherence tomography.

Device: Oculus PENTACAM HR
The Pentacam HR is a high-resolution rotating Scheimpflug camera system for anterior segment analysis already established on the market. It is used as representative device for advanced anterior segment analysis such as anterior and posterior corneal topography and corneal pachymetry.

Device: Zeiss ATLAS 9000
ATLAS is a corneal topography system used as representative device for measurement of anterior corneal curvature (anterior corneal topography).




Primary Outcome Measures :
  1. In-vivo Repeatability [ Time Frame: 3 months ]

    The in-vivo repeatability is calculated as the square root of the residual variance of a mixed-effects ANOVA model (using subject as a random effect, and eye within subject as a fixed effect), which we multiply with a factor of square root of two (in order to make it commensurate with the standard deviation of the differences between two independent measurements of each eye in the study sample).

    For comparator devices, the in-vivo repeatability will be assessed as well, based on two independent measurements of the same eye.


  2. Limits of Agreement [ Time Frame: 3 months ]
    For each measurand, a comparator device was defined which represents the current clinical standard. For the comparator device, for each measured parameter the mean value per eye is obtained (this value serves as the "best guess" of the true value of this parameter for one particular eye). Then, for each examination of EYESTAR 900, the difference with respect to this comparator mean value is calculated. For the resulting differences per parameter, the interval spanning the mean difference ± 1.96 * the first standard deviation of the differences is obtained. This interval quantifies the limits of agreement, spanning 95% of the expected measurement differences between EYESTAR 900 and the comparator device.

  3. Confidence Interval of Differences [ Time Frame: 3 months ]
    The mean deviation with respect to a comparator device ("equivalence") is determined as the confidence interval of a double-sided Wilcoxon test (α=0.05) of the mean measurement difference between the investigational device and the comparator device, computed over the study sample.


Secondary Outcome Measures :
  1. Raw OCT Data [ Time Frame: 3 months ]
    Acquisition of volumetric OCT Data of the eye. This secondary study outcome allows for the improvement of existing algorithms, development of additional measurands and for retrospective analysis but will not be processed within the scope of this clinical trial.

  2. Raw Image Data [ Time Frame: 3 months ]
    Acquisition of photographic images of the eye. This secondary study outcome allows for the improvement of existing algorithms, development of additional measurands and for retrospective analysis but will not be processed within the scope of this clinical trial.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

voluntary participation of subjects of legal age, irrespective of age, gender, ethnicity, of which:

  • participants with healthy eyes,
  • participants with corneal scarring,
  • participants with irregular astigmatism.

Exclusion Criteria:

  • Involuntary participation or inability to provide consent,
  • persons of vulnerable populations,
  • persons unable or unwilling to follow instructions,
  • persons unable to maintain fixation for the duration of the examinations,
  • persons with active inflammation or infections of the eye,
  • persons with a tear film break up time of less than 5 sec.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04392349


Locations
Layout table for location information
Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
Haag-Streit AG
Investigators
Layout table for investigator information
Principal Investigator: David Goldblum, Prof. Dr. University Hospital, Basel, Switzerland
Additional Information:
Layout table for additonal information
Responsible Party: Haag-Streit AG
ClinicalTrials.gov Identifier: NCT04392349    
Other Study ID Numbers: 1023707
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haag-Streit AG:
Optical Biometry
Corneal Topography
Additional relevant MeSH terms:
Layout table for MeSH terms
Cataract
Keratoconus
Lens Diseases
Eye Diseases
Corneal Diseases