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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:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00348205
First received: June 30, 2006
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  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
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: at each visit up to 24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: at each visit up to 24 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hyperopia with or without astigmatism.

Exclusion Criteria:

  • Contraindications to LASIK.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348205

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

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00348205     History of Changes
Other Study ID Numbers: 369
Study First Received: June 30, 2006
Last Updated: December 20, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Astigmatism
Hyperopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013