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
  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
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: 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 July 28, 2014