A Clinical Evaluation of the Next Generation Diagnostic Instrument (NGDI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00347594
First received: June 30, 2006
Last updated: January 15, 2014
Last verified: January 2014

June 30, 2006
January 15, 2014
August 2005
September 2006   (final data collection date for primary outcome measure)
Measurement of aberrations with the NGDI and the Zywave II. [ Time Frame: Single visit ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00347594 on ClinicalTrials.gov Archive Site
Measurement of corneal topography and pachymetry with the NGDI and the Orbscan IIz. [ Time Frame: Single visit ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Clinical Evaluation of the Next Generation Diagnostic Instrument (NGDI)
A Clinical Evaluation of the Next Generation Diagnostic Instrument (NGDI)

The purpose of this study is to measure the aberrations, corneal surface topography and pachymetry of normal human eyes with the NGDI.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Healthy
  • Device: Next Generation Diagnostic Instrument (NGDI)
    Measurement of the aberrations, corneal surface topography, and pachymetry of normal human eyes
  • Device: Zyoptix Diagnostic Workstation (ZDW)
    Measurement of the aberrations, corneal surface topography, and pachymetry of normal human eyes
  • Experimental: Next Generation Diagnostic Instrument
    Next Generation Diagnostic Instrument (NGDI)
    Intervention: Device: Next Generation Diagnostic Instrument (NGDI)
  • Active Comparator: Zyoptix Diagnostic Workstation
    Zyoptix Diagnostic Workstation (ZDW)
    Intervention: Device: Zyoptix Diagnostic Workstation (ZDW)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
September 2006
September 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • +10.00D to -20.00D of absolute spherical ametropia
  • Must be part of the Bausch & Lomb research clinic
  • Snellen visual acuity must be correctable to 20/25

Exclusion Criteria:

  • No more than -6.00D of refractive astigmatism
Both
21 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00347594
GVC2-03-052
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Principal Investigator: Michele Lagana Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP