NCT00347594

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Aug 2005

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

January 17, 2014

Status Verified

January 1, 2014

Enrollment Period

1.1 years

First QC Date

June 30, 2006

Last Update Submit

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
  • 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.

Sponsors & Collaborators

Study Sites (1)

Bausch & Lomb

Rochester, New York, 14609, United States

Location

Study Officials

  • Michele Lagana

    Bausch & Lomb Incorporated

    PRINCIPAL INVESTIGATOR

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 1, 2005

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

January 17, 2014

Record last verified: 2014-01

Locations

US(1)