Aphakic Eye, Cataract, Eyes With Corneal Abnormality, Normal Non-fluency
Conditions
Brief summary
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
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.
Interventions
None listed
Sponsors
Nidek Co. LTD.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. Subjects who sign an informed consent form to participate in the clinical trial. 3. Subjects who agree to take the qualifying eye examination and a series of devices measurements. 4. Subjects able to fixate on a target. 5. 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
1. Pregnancy. 2. Any eye condition preventing use of any of the instruments used in the study. 3. Any eye condition which might impair the validity of results from any of the instruments used in the study. 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement and Precision Endpoints Analyses | Subjects will be followed for the duration of the procedure, up to one day. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Adverse Events Found During the Study | Subjects will be followed for the duration of the procedure, up to one day. | The safety endpoint is to evaluate any adverse events associated with the Nidek optical biometer or the predicate or reference devices. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Additional Analyses for the Agreement Portion of the Study | Subjects will be followed for the duration of the procedure, up to one day. | 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. |
Countries
United States
Outcome results
None listed