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To Investigate the Precision and Agreement of SS-1000 and Pentacam in a Repeatability and Reproducibility Trial (PASP)

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ClinicalTrials.gov Identifier: NCT02077790
Recruitment Status : Completed
First Posted : March 4, 2014
Last Update Posted : March 4, 2014
Sponsor:
Information provided by (Responsible Party):
Tomey Corporation

Brief Summary:

This study is to support the substantial equivalence of the SS-1000 to the predicate device Pentacam.

Primary Objective -The primary objective of the trial is to evaluate the precision of the SS-1000 and Pentacam in measuring the anterior segment parameters in an eye, including Corneal Curvature, Corneal Thickness, Anterior Chamber Depth and Cornea Volume.

Secondary Objectives

  • To investigate the repeatability (intra-instrument) of SS-1000 and Pentacam in measuring the anterior segment parameters in an eye
  • To investigate the reproducibility (inter-instrument) of SS-1000 and Pentacam in measuring the anterior segment parameters in an eye
  • To investigate the agreement between SS-1000 and Pentacam in measuring the anterior segment parameters in an eye

Study design

-The trial design is a prospective precision trial with the following factors: The trial will be conducted at one investigational site. The site will have three SS-1000 devices and three Pentacam devices available. Three certified operators (#1, #2 and #3) will be randomly assigned to one set of devices (one SS-1000 and one Pentacam), such that operator effect are confounded with instrument effect. All participants will have one visit and undergo the same set of assessments. Each assessment will consist of 2 consecutive readings (M1, M2).


Condition or disease Intervention/treatment Phase
Evaluate the Agreement and Precision of Device SS-1000 and the Predicate Device the Pentacam in a Reproducibility and Repeatability Trial Device: CASIA Cornea/Anterior Segment OCT SS-1000 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: To Investigate the Precision and Agreement of SS-1000 and the Predicate Device Pentacam in a Repeatability and Reproducibility Trial (PASP)
Study Start Date : September 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Substantial Equivalence
The CASIA Cornea/Anterior Segment OCT SS-1000 was used on all subjects for this study.
Device: CASIA Cornea/Anterior Segment OCT SS-1000
The SS-1000 is a three-dimensional, non-contact, non-invasive high resolution optical coherence tomography imaging device based on the principal of "Swept Source" OCT. The system achieves high resolution imaging of 10 μm (Axial) and 30 μm (Transverse) and high speed scanning of 30,000 A-scans per second.
Other Name: OCULUS Pentacam Scheimpflug Camera




Primary Outcome Measures :
  1. Precision [ Time Frame: within 2 hours ]

    Corneal Curvature

    1. AKf: axial power value of the flattest meridian [Anterior] (mm)
    2. AKs: axial power value of the steepest meridian [Anterior] (mm)
    3. PKf: axial power value of the flattest meridian [Posterior] (mm)
    4. PKs: axial power value of the steepest meridian [Posterior] (mm)

    Corneal thickness

    1. CCT: thickness value of central cornea (µm)
    2. PCT2: thickness value of peripheral cornea at intersection between the 2-mm diameter circle and the nasal horizontal meridian (µm)
    3. PCT4: thickness value of peripheral cornea at intersection between the 4-mm diameter circle and the nasal horizontal meridian (µm)
    4. PCT6: thickness value of peripheral cornea at intersection between the 6-mm diameter circle and the nasal horizontal meridian (µm)

    ACD: Anterior Chamber Depth (mm)

    Cornea Volume (mm3)



Secondary Outcome Measures :
  1. Repeatability, reproducibility and agreement [ Time Frame: within 2 hours ]
    1. To investigate the repeatability (intra-instrument) of SS-1000 and Pentacam in measuring the anterior segment parameters in an eye
    2. To investigate the reproducibility (inter-instrument) of SS-1000 and Pentacam in measuring the anterior segment parameters in an eye
    3. To investigate the agreement between SS-1000 and Pentacam in measuring the anterior segment parameters in an eye



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female or male age 22 years or older at time of screening
  • Able to fixate at the internal fixation
  • Able to open eyes sufficiently to enable a full image area
  • Written informed consent obtained from subject before any investigational assessment

Eyes with one of the following cornea conditions (Francis BA, 2008):

  1. Normal cornea (CCT between 511-580 µm with or without pathology)
  2. Thin cornea, i.e. previous refractive surgery, corneal ectasia, keratoconus (CCT ≤510 µm with or without pathology)
  3. Thick cornea, i.e. Fuchs' dystrophy, bullous keratopathy, corneal edema (CCT >580 µm with or without pathology)

Exclusion Criteria:

  • Use of rigid contact lenses within one week from start of trial
  • Use of soft contact lenses within 24 hours of any trial measurement
  • Aphakic eyes
  • Eyes with a history of intraocular, corneal surgery, except refractive surgery
  • Currently on mydriatic and/or miotic medication that can affect ocular physiology
  • Seriously ill or unconscious subject, mentally ill person, mentally handicapped person, person who is unable to read or write

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077790


Locations
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Japan
Ehime University Hospital
Shizukawa, Toon, Ehime, Japan, 791-0295
Sponsors and Collaborators
Tomey Corporation
Investigators
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Principal Investigator: Atsushi Shiraishi, M.D., Ph.D. Ehime University Hospital

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Responsible Party: Tomey Corporation
ClinicalTrials.gov Identifier: NCT02077790    
Other Study ID Numbers: 684-a01
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: March 2014