Status:
COMPLETED
Clinical Trial ES 900 - 2019
Lead Sponsor:
Haag-Streit AG
Collaborating Sponsors:
University Hospital, Basel, Switzerland
Conditions:
Optical Biometry of the Human Eye
General Analysis of the Anterior Chamber of the Human Eye
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this clinical trial is to assess the clinical performance of the investigational device. To that end, the Limits of Agreement with respect to comparator devices are analyzed. ...
Detailed Description
The EYESTAR900 (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).
Eligibility Criteria
Inclusion
- At least one eye of each subject needs to fulfill one of the following inclusion criteria:
- volunteers with normal phakic eye;
- patients seeking cataract surgery;
- patients with pseudophakic eye;
- patients with oil-filled eye;
- patients with aphakic eye.
Exclusion
- Exclusion criteria per subject:
- underage patients (younger than 18 years);
- vulnerable patients;
- inability to give informed consent;
- Exclusion criteria per eye:
- inability to maintain stable fixation;
- corneal lesions or scarring;
- previous corneal surgery (except: pseudophakic eyes, oil-filled eyes, aphakic eyes);
- previous intraocular surgery (except: pseudophakic eyes, oil-filled eyes, aphakic eyes);
- active inflammation of the eye;
- active infection of the eye;
- tear film break up time of less than 5 sec.
Key Trial Info
Start Date :
July 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04112472
Start Date
July 11 2019
End Date
September 1 2019
Last Update
November 21 2019
Active Locations (1)
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1
University Hopital Basel
Basel, Switzerland, 4056