Clinical Trial ES 900 - 2016

The primary objective of this clinical trial is to assess the clinical performance of the investigational device. To that end, for each measure and the in-vivo repeatability will be quantified, as well as the mean measurement 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 improvements of existing algorithms, development of additional measure and 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

EYESTAR 900 (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): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4056
    • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years or older;
• volunteers with phakic eyes, no cataract surgery indicated and with existing vitreous;
• patients seeking cataract surgery;
• patients with pseudophakic eye;
• patients with oil-filled eye;
• patients with aphakic eye.

Exclusion Criteria:

• underage patients (younger than 18 years);
• vulnerable patients;
• inability to give informed consent;
• inability to maintain stable fixation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

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, Eyestar 900 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 experimental intervention is an optical, non-contact examination with the investigational device EYESTAR 900.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Keratometry-Measurands	In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for K1, K2 (R1, R2, AST) in [dpt]; Axis in [°].	Through study completion, approximately 9 months.
Axial measurands	In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for CCT in [µm]; AD in [mm]; ACD in [mm]; LT in [mm]; AL in [mm].	Through study completion, approximately 9 months
Imaging	In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for WTW in [mm]; ICX, ICY in [mm]; PD in [mm]; PCX, PCY in [mm].	Through study completion, approximately 9 months
Anterior corneal topography	In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for elevation in [µm ]; axial curvature in [dpt].	Through study completion, approximately 9 months
Posterior corneal topography	In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for elevation in [µm]; axial curvature in [dpt].	Through study completion, approximately 9 months
Corneal pachymetry	In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for CT in [µm ].	Through study completion, approximately 9 months
Posterior corneal keratometry	In-vivo repeatability and confidence interval of mean deviation with respect to comparator device, for PK1, PK2 (PR1, PR2, PAST) in [dpt]; PAxis in [°].	Through study completion, approximately 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aquisition of volumetric OCT Data of the eye.	Data is collected, but not processed within the scope of this clinical trial.	Through study completion, approximately 9 months
Aquisition of photographic images of the eye.	Data is collected, but not processed within the scope of this clinical trial.	Through study completion, approximately 9 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 9, 2017
• Primary Completion (ACTUAL): February 12, 2019
• Study Completion (ACTUAL): February 12, 2019

Study Registration Dates

• First Submitted: November 10, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (ACTUAL): December 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 22, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1023191

Drug and device information, study documents

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