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

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Normal Non-fluency; Aphakic Eye; Eyes With Corneal Abnormality

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.

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Greensboro, North Carolina, United States, 27410-2548
      • Physicians Protocol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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.

Secondary Outcome Measures

Outcome Measure	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.

Other Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Nidek Co. LTD.
• Investigators: Principal Investigator: Karl G Stonecipher, M.D., Physicians Protocol

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: November 7, 2012
• First Submitted That Met QC Criteria: November 14, 2012
• First Posted (Estimate): November 21, 2012

Study Record Updates

• Last Update Posted (Estimate): June 28, 2013
• Last Update Submitted That Met QC Criteria: June 26, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Aphakia
• Other Study ID Numbers: AL-3