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

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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

Study Description
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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 Phase
Hyperopia Astigmatism Device: Technolas 217z Zyoptix Laser Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2005
Actual Primary Completion Date : January 2009
Actual Study Completion Date : March 2009

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months [ Time Frame: 24 months ]
  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, New York
Bausch & Lomb
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
More Information
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00348205    
Other Study ID Numbers: 369
First Posted: July 4, 2006    Key Record Dates
Results First Posted: September 14, 2020
Last Update Posted: September 14, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Astigmatism
Hyperopia
Refractive Errors
Eye Diseases