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

Bausch + Lomb

Status: Completed

Conditions: Healthy

Treatments: Device: Next Generation Diagnostic Instrument (NGDI); Device: Zyoptix Diagnostic Workstation (ZDW)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00347594

GVC2-03-052

Details and patient eligibility

About

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

Enrollment: 76 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Next Generation Diagnostic Instrument

Experimental group

Description:

Next Generation Diagnostic Instrument (NGDI)

Treatment:

Device: Next Generation Diagnostic Instrument (NGDI)

Zyoptix Diagnostic Workstation

Active Comparator group

Description:

Zyoptix Diagnostic Workstation (ZDW)

Treatment:

Device: Zyoptix Diagnostic Workstation (ZDW)