Clinical Trial ES 900 - 2016

General Analysis of the Anterior Chamber of the Human Eye Clinical Trial

Official title:

Clinical Trial ES 900 - 2016

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382288
• Other study ID #: 1023191
• Status: Completed
• Phase: N/A
• Start date: June 9, 2017
• Est. completion date: February 12, 2019

Study information

• Verified date: February 2019
• Source: Haag-Streit AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 12, 2019
• Est. primary completion date: February 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
Haag-Streit AG	University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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