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

This study has been completed.

Sponsor:

Information provided by:

Bausch & Lomb Incorporated

ClinicalTrials.gov Identifier:

NCT00347594

First received: June 30, 2006

Last updated: November 12, 2010

Last verified: November 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

June 30, 2006

Last Updated Date

November 12, 2010

Start Date ^ICMJE

August 2005

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00347594 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Healthy

Intervention ^ICMJE

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

Study Arm (s)

Experimental: NGDI
Next Generation Diagnostic Instrument (NGDI)

Intervention: Device: Next Generation Diagnostic Instrument (NGDI)
Active Comparator: ZDW
Zyoptix Diagnostic Workstation (ZDW)

Intervention: Device: Zyoptix Diagnostic Workstation (ZDW)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2006

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00347594

Other Study ID Numbers ^ICMJE

GVC2-03-052

Has Data Monitoring Committee

Responsible Party

Mohinder Merchea, Bausch & Lomb Incorporated

Study Sponsor ^ICMJE

Bausch & Lomb Incorporated

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michele Lagana

Bausch & Lomb Incorporated

Information Provided By

Bausch & Lomb Incorporated

Verification Date

November 2010

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

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