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

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.
ClinicalTrials.gov Identifier: NCT00348205
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : December 28, 2012
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery treatments for hyperopia and astigmatism.

Condition or disease Intervention/treatment
Hyperopia Astigmatism Device: Technolas 217z Zyoptix Laser

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2005
Primary Completion Date : January 2009
Study Completion Date : March 2009

Arm Intervention/treatment
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.



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

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


Information from the National Library of Medicine

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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.

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

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

Additional relevant MeSH terms:
Astigmatism
Hyperopia
Refractive Errors
Eye Diseases