Comparative Study of the Optical Biometer for Measurements of the Eye

NCT01729962 | Completed

• 1 other identifier: AL-3
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of Adverse Events Found During the Study

  Subjects will be followed for the duration of the procedure, up to one day.

Other Outcomes (1)

• Additional Analyses for the Agreement Portion of the Study

  Subjects will be followed for the duration of the procedure, up to one day.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.
• Subjects who sign an informed consent form to participate in the clinical trial.
• Subjects who agree to take the qualifying eye examination and a series of devices measurements.
• Subjects able to fixate on a target.
• 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.

You may not qualify if:

• Pregnancy.
• Any eye condition preventing use of any of the instruments used in the study.
• Any eye condition which might impair the validity of results from any of the instruments used in the study.
• 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.

Sponsors & Collaborators

• Nidek Co. LTD.: lead

Study Sites (1)

Physicians Protocol

Greensboro, North Carolina, 27410-2548, United States

Location

MeSH Terms

Conditions

Cataract; Aphakia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Karl G Stonecipher, M.D.

  Physicians Protocol

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: November 21, 2012
• Study Start: December 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 28, 2013

Record last verified: 2013-06

Locations

US (1)