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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hyperopia
Astigmatism
Intervention Device: Technolas 217z Zyoptix Laser
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Technolas 217z Zyoptix System
Hide Arm/Group Description

Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.

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.

Period Title: Overall Study
Started 80
Completed 78
Not Completed 2
Arm/Group Title Technolas 217z Zyoptix System
Hide Arm/Group Description

Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.

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.

Overall Number of Baseline Participants 80
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
159
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants
49.5  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
Female
45
  56.3%
Male
35
  43.8%
1.Primary Outcome
Title Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of eyes available for uncorrected visual acuity assessment at 12 months and 24 months were included in the analysis.
Arm/Group Title Technolas 217z Zyoptix System
Hide Arm/Group Description:

Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.

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.

Overall Number of Participants Analyzed 74
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
147
Count of Units
Unit of Measure: eyes
12 months Number Analyzed 147 eyes
147
 100.0%
24 months Number Analyzed 143 eyes [1] 
140
  97.9%
[1]
72 participants
2.Primary Outcome
Title Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The number of eyes available for manifest refraction spherical equivalent assessment at 12 months were included in the analysis.
Arm/Group Title Technolas 217z Zyoptix System
Hide Arm/Group Description:

Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.

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.

Overall Number of Participants Analyzed 74
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
147
Count of Units
Unit of Measure: eyes
Within 0.50 D
100
  68.0%
Within 1.00 D
142
  96.6%
3.Primary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The number of eyes available for manifest refraction spherical equivalent assessment at 24 months were included in the analysis.
Arm/Group Title Technolas 217z Zyoptix System
Hide Arm/Group Description:

Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.

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.

Overall Number of Participants Analyzed 72
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
143
Count of Units
Unit of Measure: eyes
Within 0.50 D
97
  67.8%
Within 1.00 D
129
  90.2%
4.Primary Outcome
Title Refractive Stability - Categorical Change Between Month 1 and Month 3
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
There were 139 eyes with manifest refraction spherical equivalent assessments at both Month 1 and Month 3 for this outcome assessment.
Arm/Group Title Technolas 217z Zyoptix System
Hide Arm/Group Description:

Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.

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.

Overall Number of Participants Analyzed 70
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
139
Count of Units
Unit of Measure: eyes
135
  97.1%
5.Primary Outcome
Title Refractive Stability - Mean Change Between Month 1 and Month 3
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
There were 139 eyes with manifest refraction spherical equivalent assessments at both Month 1 and Month 3 for this outcome assessment.
Arm/Group Title Technolas 217z Zyoptix System
Hide Arm/Group Description:

Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.

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.

Overall Number of Participants Analyzed 70
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
139
Mean (Standard Deviation)
Unit of Measure: diopter
0.12  (0.40)
6.Primary Outcome
Title Induced Astigmatism
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
There were 32 sphere eyes assessed for this outcome measure.
Arm/Group Title Technolas 217z Zyoptix System
Hide Arm/Group Description:

Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.

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.

Overall Number of Participants Analyzed 16
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
32
Count of Units
Unit of Measure: eyes
0
   0.0%
7.Secondary Outcome
Title Loss of Best Spectacle-corrected Visual Acuity (BSCVA)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The number of eyes available for uncorrected visual acuity assessment at 12 months and 24 months were included in the analysis.
Arm/Group Title Technolas 217z Zyoptix System
Hide Arm/Group Description:

Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.

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.

Overall Number of Participants Analyzed 78
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
155
Count of Units
Unit of Measure: eyes
12 months Number Analyzed 155 eyes
1
   0.6%
24 months Number Analyzed 150 eyes [1] 
3
   2.0%
[1]
75 participants
Time Frame 24 months
Adverse Event Reporting Description Adverse events (AEs) were assessed throughout the study. AEs were not coded (therefore, there is no source vocabulary).
 
Arm/Group Title Technolas 217z Zyoptix System
Hide Arm/Group Description

Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.

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.

All-Cause Mortality
Technolas 217z Zyoptix System
Affected / at Risk (%)
Total   0/80 (0.00%) 
Hide Serious Adverse Events
Technolas 217z Zyoptix System
Affected / at Risk (%)
Total   1/80 (1.25%) 
Injury, poisoning and procedural complications   
Suction break *  1/80 (1.25%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Technolas 217z Zyoptix System
Affected / at Risk (%)
Total   0/80 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Contact sponsor directly for details.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Bausch Health
Phone: 908-300-9920
EMail: susan.harris@bauschhealth.com
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00348205    
Other Study ID Numbers: 369
First Submitted: June 30, 2006
First Posted: July 4, 2006
Results First Submitted: August 11, 2020
Results First Posted: September 14, 2020
Last Update Posted: September 14, 2020