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

NCT02077790 | Completed

• 1 other identifier: 684-a01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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).

Conditions

Evaluate the Agreement and Precision of Device SS-1000 and the Predicate Device the Pentacam in a Reproducibility and Repeatability Trial

Outcome Measures

Primary Outcomes (1)

• Precision

  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)

  within 2 hours

Secondary Outcomes (1)

• Repeatability, reproducibility and agreement

  within 2 hours

Study Arms (1)

Substantial Equivalence

NO INTERVENTION

The CASIA Cornea/Anterior Segment OCT SS-1000 was used on all subjects for this study.

Device: CASIA Cornea/Anterior Segment OCT SS-1000

Interventions

CASIA Cornea/Anterior Segment OCT SS-1000 DEVICE

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.

Also known as: OCULUS Pentacam Scheimpflug Camera

Substantial Equivalence

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tomey Corporation: lead

Study Sites (1)

Ehime University Hospital

Shizukawa, Toon, Ehime, 791-0295, Japan

Location

Study Officials

• Atsushi Shiraishi, M.D., Ph.D.

  Ehime University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: March 4, 2014
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 4, 2014

Record last verified: 2014-03

Locations

JP (1)