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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014