Clinical Trial ES 900 - 2016

NCT03382288 | Completed

• 1 other identifier: 1023191
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Optical Biometry of the Human Eye; General Analysis of the Anterior Chamber of the Human Eye

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Aquisition of volumetric OCT Data of the eye.

  Through study completion, approximately 9 months

• Aquisition of photographic images of the eye.

  Through study completion, approximately 9 months

Study Arms (1)

Examination of participants

EXPERIMENTAL

Examination of participants by means of the investigational device, Eyestar 900 as well as the comparative devices.

Device: EYESTAR 900

Interventions

EYESTAR 900 DEVICE

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.

Examination of participants

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Haag-Streit AG: lead
• University Hospital, Basel, Switzerland: collaborator

Study Sites (1)

University Hospital Basel

Basel, 4056, Switzerland

Location

Study Officials

• David Goldblum, Prof. Dr.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: December 22, 2017
• Study Start: June 9, 2017
• Primary Completion: February 12, 2019
• Study Completion: February 12, 2019
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

CH (1)