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This study has been withdrawn prior to enrollment.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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014