Back to resultsA Study to Evaluate the Safety and Effectiveness of the Technols 217z Zyoptix System for Hyperopia
Primary Purpose
Hyperopia, Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Technolas 217z Zyoptix Laser
Sponsored by
About this trial
This is an interventional treatment trial for Hyperopia
Eligibility Criteria
Inclusion Criteria: Hyperopia with or without astigmatism. Exclusion Criteria: Contraindications to LASIK.
Sites / Locations
- Bausch & Lomb
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Technolas 217z Zyoptix System
Arm Description
Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.
Outcomes
Primary Outcome Measures
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 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.
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
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
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
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
Percentage of eyes which had >2.00 Diopter of induced refractive cylinder for those eyes treated for spherical hyperopia only.
Secondary Outcome Measures
Loss of Best Spectacle-corrected Visual Acuity (BSCVA)
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.
Full Information
NCT ID
NCT00348205
First Posted
June 30, 2006
Last Updated
September 10, 2020
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00348205
Brief Title
A Study to Evaluate the Safety and Effectiveness of the Technols 217z Zyoptix System for Hyperopia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery treatments for hyperopia and astigmatism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperopia, Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Technolas 217z Zyoptix System
Arm Type
Experimental
Arm Description
Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.
Intervention Type
Device
Intervention Name(s)
Technolas 217z Zyoptix Laser
Intervention Description
Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.
Primary Outcome Measure Information:
Title
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months
Time Frame
24 months
Title
Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia.
Description
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).
Time Frame
12 months
Title
The Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia
Description
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).
Time Frame
24 months
Title
Refractive Stability - Categorical Change Between Month 1 and Month 3
Description
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).
Time Frame
Month 1, Month 3
Title
Refractive Stability - Mean Change Between Month 1 and Month 3
Description
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).
Time Frame
1 month, 3 months
Title
Induced Astigmatism
Description
Percentage of eyes which had >2.00 Diopter of induced refractive cylinder for those eyes treated for spherical hyperopia only.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Loss of Best Spectacle-corrected Visual Acuity (BSCVA)
Description
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.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hyperopia with or without astigmatism.
Exclusion Criteria:
Contraindications to LASIK.
Facility Information:
Facility Name
Bausch & Lomb
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety and Effectiveness of the Technols 217z Zyoptix System for Hyperopia
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