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

January 15, 2014 updated by: Bausch & Lomb Incorporated
The purpose of this study is to measure the aberrations, corneal surface topography and pachymetry of normal human eyes with the NGDI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14609
        • Bausch & Lomb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of aberrations with the NGDI and the Zywave II.
Time Frame: Single visit
Single visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement of corneal topography and pachymetry with the NGDI and the Orbscan IIz.
Time Frame: Single visit
Single visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Principal Investigator: Michele Lagana, Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

June 30, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

January 17, 2014

Last Update Submitted That Met QC Criteria

January 15, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GVC2-03-052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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