Comparative Study of the Optical Biometer for Measurements of the Eye

Completed

Conditions studied: Normal Non-fluency, Cataract, Aphakic Eye, Eyes With Corneal Abnormality

In brief

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.

Key facts

Study ID

NCT01729962

Run by

Nidek Co. LTD.

People needed

125

Starts

2012-12-01

Expected to finish

2013-05-01

Last updated by the study team

2013-06-28

Who can join

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

You may qualify if…

• 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:
• Normal eyes: Subjects with a natural lens without a cataract, corneal abnormalities or prior keratorefractive surgery.
• Eyes with Cataracts: Subjects with a pre-existing cataract without corneal abnormalities or prior keratorefractive surgery.
• Eyes without a Natural Lens: Subjects that are pseudophakic or aphakic without corneal abnormalities or prior keratorefractive surgery.
• Eyes with Corneal Abnormality: Subjects with a corneal abnormality and a natural lens without a cataract, or Subjects post keratorefractive surgery and a natural lens without a cataract.

You may not qualify if…

• 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.

Where it is running

• Physicians Protocol — Greensboro, North Carolina, United States

Full record on ClinicalTrials.gov

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