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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Next Generation Diagnostic Instrument (NGDI); Device: Zyoptix Diagnostic Workstation (ZDW)

• Registration Number: NCT00347594
• Lead Sponsor: Bausch & Lomb Incorporated

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 available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-06-30
• Study First Posted: 2006-07-04
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-15
• Last Update Posted: 2014-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Next Generation Diagnostic Instrument	Next Generation Diagnostic Instrument (NGDI)	Next Generation Diagnostic Instrument (NGDI)
Zyoptix Diagnostic Workstation	Zyoptix Diagnostic Workstation (ZDW)	Zyoptix Diagnostic Workstation (ZDW)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bausch & Lomb; 🇺🇸 Rochester, New York, United States