NCT01729962

Comparative Study of the Optical Biometer for Measurements of the Eye

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 125 (actual)
• Sponsor: Nidek Co. LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Normal Non-fluency
• Cataract
• Aphakic Eye
• Eyes With Corneal Abnormality

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-04-01
• Completion: 2013-05-01
• First posted: 2012-11-21
• Last updated: 2013-06-28

Locations

1 site across 1 country: United States