CompletedNot Applicable

Comparative Study of the Optical Biometer for Measurements of the Eye

United States125 participantsStarted 2012-12

Plain-language summary

The primary purpose of this comparative clinical study is to collect clinical data to demonstrate the equivalence of the investigational device to the predicate device for measurements of the eye. The secondary purpose is to evaluate any adverse events that occur during the clinical study.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subjects who can follow the instructions by the Principal/Clinical Investigator or clinical staff at the clinical site, and can visit on scheduled examination dates.
✓. Subjects who sign an informed consent form to participate in the clinical trial.
✓. Subjects who agree to take the qualifying eye examination and a series of devices measurements.
✓. Subjects able to fixate on a target.
✓. Subjects must meet at lease one of the following criteria:

Exclusion criteria

✕. Pregnancy.
✕. Any eye condition preventing use of any of the instruments used in the study.
✕. Any eye condition which might impair the validity of results from any of the instruments used in the study.
✕. Any medical condition, which, in the Investigator's judgment, interferes with the subject's ability to comply with the protocol, compromises subject safety, or interferes with the interpretation of the study results.

What they're measuring

Agreement and Precision Endpoints Analyses

Timeframe: Subjects will be followed for the duration of the procedure, up to one day.

Trial details

NCT IDNCT01729962

SponsorNidek Co. LTD.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2013-04

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