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NCT00347997 Clinical Trial

A Study to Evaluate the Safety and Effectiveness of the 217z Laser With Zyoptix for Lasik

Myopia Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00347997
Other study ID # 385
Secondary ID
Status Withdrawn
Phase N/A
First received June 30, 2006
Last updated December 7, 2011

Study information
Verified date December 2011
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

A Study to demonstrate the safety and efficacy of wavefront laser refractive surgery treatments for myopia and astigmatism.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Myopia with or without astigmatism.

Exclusion Criteria:

- Contraindications to LASIK.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• 217z Laser
LASIK correction of myopia and myopic astigmatism

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Outcome
Type Measure Description Time frame Safety issue
Primary Visual acuity 24 months No
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