NCT00347594

Completed

A Clinical Evaluation of the Next Generation Diagnostic Inst...

Bausch & Lomb Incorporated Source

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Other study identifiers

Sponsor study identifier

GVC2-03-052

Study Type

interventional

Actual enrollment (reported)

76

Locations

1 country

Sites

1

Timeline

Study Start

August 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2006

Actual (reported)

Study Completion

September 2006

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 76 participants
Study completion date: September 2006
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
June 30, 2006
Actual (reported)
First Posted
July 4, 2006
Actual (reported)
Primary Completion
September 2006
Actual (reported)
Study Completion
September 2006
Actual (reported)

Last Updated: January 17, 2014
Status Verified: January 2014
Last Update Submitted: January 15, 2014

Conditions

Healthy

Keywords

Corneal surface topographyOcular aberrations

Outcome Measures

Primary Outcomes (1)

Measurement of aberrations with the NGDI and the Zywave II.
Single visit

Secondary Outcomes (1)

Measurement of corneal topography and pachymetry with the NGDI and the Orbscan IIz.
Single visit

Study Arms (2)

Next Generation Diagnostic Instrument

EXPERIMENTAL

Next Generation Diagnostic Instrument (NGDI)

Device: Next Generation Diagnostic Instrument (NGDI)

Zyoptix Diagnostic Workstation

ACTIVE COMPARATOR

Zyoptix Diagnostic Workstation (ZDW)

Device: Zyoptix Diagnostic Workstation (ZDW)

Interventions

Next Generation Diagnostic Instrument (NGDI)Device

Measurement of the aberrations, corneal surface topography, and pachymetry of normal human eyes

Next Generation Diagnostic Instrument

Zyoptix Diagnostic Workstation (ZDW)Device

Measurement of the aberrations, corneal surface topography, and pachymetry of normal human eyes

Zyoptix Diagnostic Workstation

Eligibility Criteria

Age21 Years - 75 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

+10.00D to -20.00D of absolute spherical ametropia
Must be part of the Bausch \& Lomb research clinic

Sponsors & Collaborators

Bausch & Lomb Incorporated
Industrylead

Study Sites (1)

Bausch & Lomb

Rochester, New York, 14609, United States

Study Officials

Michele Lagana
Bausch & Lomb Incorporated
PRINCIPAL INVESTIGATOR

Enrollment

76 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

August 2005

Date type not reported

This date has not been verified as actual or estimated.

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Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Snellen visual acuity must be correctable to 20/25

You may not qualify if:

No more than -6.00D of refractive astigmatism

Contact the study team to confirm eligibility.

Primary Completion

September 2006

Actual (reported)

Study Completion

September 2006

Actual (reported)

Last Updated

January 17, 2014

Record last verified: 2014-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00347594
Data provider: ClinicalTrials.gov
Source updated: 2014-01-17
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:58 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Next Generation Diagnostic Instrument

Zyoptix Diagnostic Workstation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations