Comparative Study of the Optical Biometer for Measurements of the Eye

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a prospective clinical study to be conducted at a single clinical site located in the United States. This study will assess the agreement of an investigational device to the predicate device and an ultrasound reference device and the precision of the investigational device with a comparison to the precision of the predicate. Any adverse events associated with the investigational device can or the predicate device will be assessed.

Official Title
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Comparative Study of the Optical Biometer for the Measurements of Axial Length, Anterior Chamber Depth, Keratometry, Corneal Cylinder Axis, Corneal Thickness, White-to-White Distance, and Pupil Diameter

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

Participation Criteria
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Eligibility Criteria
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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: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Agreement Cohort<br>All subjects in the agreement portion of the study will have a single measurement performed with each device, the Nidek optical biometer, predicate device and ultrasound reference device. Each device will be operated by a different operator. | |
| Precision Cohort<br>All subjects in the precision portion of the study will each be paired with one Nidek optical biometer and with one predicate device for a total of three Nidek optical biometer/predicate device pairs. Each of the three device pairs will be designated one and only one operator. All subjects in the precision portion of the study will have their measurements repeated three times on each of three Nidek optical biometer and predicate device pairs. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement and Precision Endpoints Analyses | The agreement of the Nidek optical biometer with the predicate device will be assessed for the following measures: Axial Length; Keratometry; Corneal Cylinder Axis; Anterior Chamber Depth; Central Corneal Thickness; White-to-White Distance; and Pupil Diameter. In addition, the agreement of the Nidek optical biometer with the ultrasound reference device will be assessed for axial length and anterior chamber depth. The precision of Nidek optical biometer and the predicate device will be assessed for the following measures: Axial Length; Keratometry; Corneal Cylinder Axis; Anterior Chamber Depth; Central Corneal Thickness; White-to-White Distance; and Pupil Diameter. | Subjects will be followed for the duration of the procedure, up to one day. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Adverse Events Found During the Study | The safety endpoint is to evaluate any adverse events associated with the Nidek optical biometer or the predicate or reference devices. | Subjects will be followed for the duration of the procedure, up to one day. |