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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Agreement Cohort | 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 | 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. |
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| 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:
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:
| Subjects will be followed for the duration of the procedure, up to one day. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Analyses for the Agreement Portion of the Study | Additional analyses will examine the intraocular lens (IOL) power calculation from the Nidek optical biometer only based on the subjects enrolled in the agreement portion of the study. | Subjects will be followed for the duration of the procedure, up to one day. |
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:
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Normal eyes(phakic eyes without cataracts or corneal disease), eyes with cataracts, eyes without a natural lens (including aphakic and pseudophakic eyes), eyes with corneal disease (including eyes post keratorefractive surgery).
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| Name | Affiliation | Role |
|---|---|---|
| Karl G Stonecipher, M.D. | Physicians Protocol | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians Protocol | Greensboro | North Carolina | 27410-2548 | United States |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001035 | Aphakia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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