Comparative Study of the Optical Biometer for Measurements of the Eye
| Status: | Completed |
|---|---|
| Conditions: | Ocular, Women's Studies |
| Therapuetic Areas: | Ophthalmology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/27/2013 |
| Start Date: | December 2012 |
| End Date: | April 2013 |
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
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.
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 keeratorefractive 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.
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