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

This study has been withdrawn prior to enrollment.
(Decision made by B&L to cancel the study, no subjects enrolled.)
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00347997
First received: June 30, 2006
Last updated: December 7, 2011
Last verified: December 2011
History of Changes
  Purpose

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


Condition Intervention
Myopia
Astigmatism
 Device: 217z Laser

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

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 0
Arms Assigned Interventions
Experimental: LASIK
LASIK correction of myopia and myopic astigmatism
 Device: 217z Laser
LASIK correction of myopia and myopic astigmatism

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Myopia with or without astigmatism.

Exclusion Criteria:

  • Contraindications to LASIK.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347997

Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Mohinder Merchea, OD, PhD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00347997     History of Changes
Other Study ID Numbers: 385
Study First Received: June 30, 2006
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Astigmatism
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013