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A Study to Evaluate the Safety and Effectiveness of the Technols 217z Zyoptix System for Hyperopia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00348205
First Posted: July 4, 2006
Last Update Posted: December 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  Purpose
A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery treatments for hyperopia and astigmatism.

Condition Intervention
Hyperopia Astigmatism Device: Technolas 217z Zyoptix Laser

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: at each visit up to 24 Months ]

Secondary Outcome Measures:
  • Safety [ Time Frame: at each visit up to 24 months ]

Enrollment: 97
Study Start Date: June 2005
Study Completion Date: March 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Technolas 217z Zyoptix System
Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.
Device: Technolas 217z Zyoptix Laser
Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hyperopia with or without astigmatism.

Exclusion Criteria:

  • Contraindications to LASIK.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348205


Locations
United States, New York
Bausch & Lomb
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
  More Information

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00348205     History of Changes
Other Study ID Numbers: 369
First Submitted: June 30, 2006
First Posted: July 4, 2006
Last Update Posted: December 28, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Astigmatism
Hyperopia
Refractive Errors
Eye Diseases