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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00347594
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : January 17, 2014
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

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

Condition or disease Intervention/treatment
Healthy Device: Next Generation Diagnostic Instrument (NGDI) Device: Zyoptix Diagnostic Workstation (ZDW)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Clinical Evaluation of the Next Generation Diagnostic Instrument (NGDI)
Study Start Date : August 2005
Primary Completion Date : September 2006
Study Completion Date : September 2006

Arm Intervention/treatment
Experimental: Next Generation Diagnostic Instrument
Next Generation Diagnostic Instrument (NGDI)
Device: Next Generation Diagnostic Instrument (NGDI)
Measurement of the aberrations, corneal surface topography, and pachymetry of normal human eyes
Active Comparator: Zyoptix Diagnostic Workstation
Zyoptix Diagnostic Workstation (ZDW)
Device: Zyoptix Diagnostic Workstation (ZDW)
Measurement of the aberrations, corneal surface topography, and pachymetry of normal human eyes



Primary Outcome Measures :
  1. Measurement of aberrations with the NGDI and the Zywave II. [ Time Frame: Single visit ]

Secondary Outcome Measures :
  1. Measurement of corneal topography and pachymetry with the NGDI and the Orbscan IIz. [ Time Frame: Single visit ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT00347594


Locations
United States, New York
Bausch & Lomb
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Michele Lagana Bausch & Lomb Incorporated

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00347594     History of Changes
Other Study ID Numbers: GVC2-03-052
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: January 17, 2014
Last Verified: January 2014

Keywords provided by Bausch & Lomb Incorporated:
Corneal surface topography
Ocular aberrations