CompletedNot Applicable

Clinical Study - ES 900 - 2020-2

Switzerland29 participantsStarted 2020-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: 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. Exclusion Criteria: * 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.

What they're measuring

In-vivo Repeatability

Timeframe: 3 months

Limits of Agreement

Timeframe: 3 months

Confidence Interval of Differences

Timeframe: 3 months

Trial details

NCT IDNCT04392349

SponsorHaag-Streit AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-08-20

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