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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
Results First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Tracking Information
First Submitted Date  ICMJE June 30, 2006
First Posted Date  ICMJE July 4, 2006
Results First Submitted Date  ICMJE August 11, 2020
Results First Posted Date  ICMJE September 14, 2020
Last Update Posted Date September 14, 2020
Study Start Date  ICMJE June 2005
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2020)
  • Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months [ Time Frame: 24 months ]
  • Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia. [ Time Frame: 12 months ]
    Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis. Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina. Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder. It is expressed in diopters (D).
  • The Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia [ Time Frame: 24 months ]
    Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis. Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina. Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder. It is expressed in diopters (D).
  • Refractive Stability - Categorical Change Between Month 1 and Month 3 [ Time Frame: Month 1, Month 3 ]
    Percentage of eyes with a change of ≤ 1.00 Diopter in manifest refraction spherical equivalent (MRSE) between postoperative refractions, performed at 1 months and 3 months after surgery. Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis. Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina. Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder. It is expressed in diopters (D).
  • Refractive Stability - Mean Change Between Month 1 and Month 3 [ Time Frame: 1 month, 3 months ]
    Mean change in manifest refraction spherical equivalent (MRSE) between postoperative refractions, performed at 1 months and 3 months after surgery. Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis. Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina. Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder. It is expressed in diopters (D).
  • Induced Astigmatism [ Time Frame: 24 months ]
    Percentage of eyes which had >2.00 Diopter of induced refractive cylinder for those eyes treated for spherical hyperopia only.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2020)
Loss of Best Spectacle-corrected Visual Acuity (BSCVA) [ Time Frame: 24 months ]
Percentage of eyes with loss of best spectacle corrected visual acuity (BSCVA) of >2 lines. Mean change in best-corrected high contrast distance visual acuity. Corrected means spectacle corrected. Visual acuity (VA) was reported as letters read correctly, and the letters read were converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters were recorded. A decrease in the number of correct letters indicates a decrease in visual acuity. Acuity was averaged across visits.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Effectiveness of the Technols 217z Zyoptix System for Hyperopia
Official Title  ICMJE Not Provided
Brief Summary A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery treatments for hyperopia and astigmatism.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hyperopia
  • Astigmatism
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Technolas 217z Zyoptix System
Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.
Intervention: Device: Technolas 217z Zyoptix Laser
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2020)
80
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hyperopia with or without astigmatism.

Exclusion Criteria:

  • Contraindications to LASIK.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00348205
Other Study ID Numbers  ICMJE 369
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bausch & Lomb Incorporated
Study Sponsor  ICMJE Bausch & Lomb Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bausch & Lomb Incorporated
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP