CompletedPhase 4

Time Study for Biometry Measurements With the Lenstar and IntraOcularLens (IOL) Master 500

United States61 participantsStarted 2012-01

Plain-language summary

The objectives of this study are to determine the time needed to complete a full set of measurements (Total Ophthalmic Exam, Subject Data Entry and Acquisition of the Measurement) by each test device, the Lenstar 900 Version i4 and IOL Master 500.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female l8 years of age or older on the date of Informed Consent.
✓. At least one eye of each subject must be a phakic eye.
✓. Subject must be able to fixate on a target.
✓. Able to understand and willing to sign tbe informed consent.

Exclusion criteria

✕. History of corneal surgery.
✕. Use of contact lenses during tbe ophthalmic exam or up to two hours prior to the exam.
✕. Any ophthalmic condition preventing use of either of the instruments used in the study.
✕. Any ophthalmic condition which might impair tbe validity of results from any of the instruments used in the study.
✕. Any medical condition, which, in tbe Investigator's judgment, interferes with the subjects ability to comply with tbe protocol, compromises subject safety, or interferes with tbe interpretation of the study results.

What they're measuring

Time to complete a full examination

Timeframe: At Study Visit (study consists of 1 visit only)

Trial details

NCT IDNCT01550939

SponsorHaag Streit USA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-03

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