Clinical Study - ES 900 - 2020-2

NCT04392349 | Completed

• 1 other identifier: 1023707
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Keratoconus

Keywords

Optical Biometry; Corneal Topography

Outcome Measures

Primary Outcomes (3)

• In-vivo Repeatability

  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.

  3 months

• Limits of Agreement

  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 months

• Confidence Interval of Differences

  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.

  3 months

Secondary Outcomes (2)

• Raw OCT Data

  3 months

• Raw Image Data

  3 months

Study Arms (2)

NORMAL

OTHER

Normal group includes eyes with healthy cornea.

Device: Haag-Streit EYESTAR 900; Device: Tomey CASIA 2; Device: Oculus PENTACAM HR; Device: Zeiss ATLAS 9000

IRREGULAR

OTHER

Irregular goup includes eyes with irregular astigmatism or corneal scarring.

Device: Haag-Streit EYESTAR 900; Device: Tomey CASIA 2; Device: Oculus PENTACAM HR; Device: Zeiss ATLAS 9000

Interventions

Haag-Streit EYESTAR 900 DEVICE

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.

IRREGULAR; NORMAL

Tomey CASIA 2 DEVICE

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.

IRREGULAR; NORMAL

Oculus PENTACAM HR DEVICE

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.

IRREGULAR; NORMAL

Zeiss ATLAS 9000 DEVICE

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

IRREGULAR; NORMAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haag-Streit AG: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Links

• Clinical Trial ES 900 - 2019

MeSH Terms

Conditions

Cataract; Keratoconus

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Corneal Diseases

Study Officials

• David Goldblum, Prof. Dr.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Julian Kool van Langenberghe, ing.

  Haag-Streit AG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 18, 2020
• Study Start: July 1, 2020
• Primary Completion: August 20, 2020
• Study Completion: December 10, 2020
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)