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
  Purpose

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


Condition Intervention
Healthy
Device: Next Generation Diagnostic Instrument (NGDI)
Device: Zyoptix Diagnostic Workstation (ZDW)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Clinical Evaluation of the Next Generation Diagnostic Instrument (NGDI)

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Measurement of aberrations with the NGDI and the Zywave II. [ Time Frame: Single visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of corneal topography and pachymetry with the NGDI and the Orbscan IIz. [ Time Frame: Single visit ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: August 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00347594     History of Changes
Other Study ID Numbers: GVC2-03-052
Study First Received: June 30, 2006
Last Updated: January 15, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014