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

Completed · Phase 4

Conditions studied: Pseudoaphakia

In brief

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.

Key facts

Study ID

NCT01550939

Run by

Haag Streit USA

People needed

61

Starts

2012-01-01

Expected to finish

2012-03-01

Last updated by the study team

2012-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects wbo meet all of the following criteria are eligible to participate in tbe study:
• 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.

You may not qualify if…

• Subjects will be excluded from the study if the following applies:
• 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.

Where it is running

• Cincinnati Eye Institute — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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