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Comparative Study of the Optical Biometer for Measurements of the Eye

NCT ID: NCT01729962

Last Updated: 2013-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-05-31

Brief Summary

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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

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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

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Normal Non-fluency Cataract Aphakic Eye Eyes With Corneal Abnormality

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nidek Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karl G Stonecipher, M.D.

Role: PRINCIPAL_INVESTIGATOR

Physicians Protocol

Locations

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Physicians Protocol

Greensboro, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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AL-3

Identifier Type: -

Identifier Source: org_study_id