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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00347594
Enrollment
76
Registered
2006-07-04
Start date
2005-08-31
Completion date
2006-09-30
Last updated
2014-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Corneal surface topography, Ocular aberrations

Brief summary

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

Interventions

DEVICENext Generation Diagnostic Instrument (NGDI)

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

DEVICEZyoptix Diagnostic Workstation (ZDW)

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

Sponsors

Bausch & Lomb Incorporated
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026