Clinical trial NCT01729962: Comparative Study of the Optical Biometer for Measurements of the Eye
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Non-fluency
Cataract
Aphakic Eye
Eyes With Corneal Abnormality
Lead sponsor: Nidek Co. LTD.
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Agreement and Precision Endpoints Analyses
timeFrame: Subjects will be followed for the duration of the procedure, up to one day.
Secondary outcomes:
measure: Evaluation of Adverse Events Found During the Study
timeFrame: Subjects will be followed for the duration of the procedure, up to one day.
Other outcomes:
measure: Additional Analyses for the Agreement Portion of the Study
timeFrame: Subjects will be followed for the duration of the procedure, up to one day.
Locations:
city: Greensboro
country: United States
facility: Physicians Protocol
state: North Carolina
Study officials:
affiliation: Physicians Protocol
name: Karl G Stonecipher, M.D.
role: PRINCIPAL_INVESTIGATOR
References: