Comparative Study of the Optical Biometer for Measurements of the Eye

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01729962
• Other study ID #: AL-3
• Status: Completed
• Phase: N/A
• First received: November 7, 2012
• Last updated: June 26, 2013
• Start date: December 2012
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: Nidek Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Physicians Protocol	Greensboro	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Nidek Co. LTD.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	No
Primary	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.	No
Secondary	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.	No