A Study to Evaluate the Safety and Effectiveness of the Technols 217z Zyoptix System for Hyperopia
Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00348205
Collaborator
(none)
80
1
1
45
1.8
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date
:
Jun 1, 2005
Actual Primary Completion Date
:
Jan 1, 2009
Actual Study Completion Date
:
Mar 1, 2009
Arms and Interventions
| 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
Primary Outcome Measures
- Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months [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. [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 [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 [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 [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 [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
- Loss of Best Spectacle-corrected Visual Acuity (BSCVA) [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
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Hyperopia with or without astigmatism.
Exclusion Criteria:
- Contraindications to LASIK.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bausch & Lomb | Rochester | New York | United States | 14609 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00348205
Other Study ID Numbers:
- 369
First Posted:
Jul 4, 2006
Last Update Posted:
Sep 14, 2020
Last Verified:
Sep 1, 2020
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Technolas 217z Zyoptix System |
|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Technolas 217z Zyoptix System |
|---|---|
| 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 Participants | 80 |
| Overall eyes | 159 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
49.5
(8.7)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
45
56.3%
|
| Male |
35
43.8%
|
Outcome Measures
| Title | Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months |
|---|---|
| Description | |
| Time Frame | 24 months |
Outcome Measure Data
| 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 |
|---|---|
| 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. |
| Measure Participants | 74 |
| Measure eyes | 147 |
| 12 months |
147
|
| 24 months |
140
|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| 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. |
| Measure Participants | 74 |
| Measure eyes | 147 |
| Within 0.50 D |
100
|
| Within 1.00 D |
142
|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| 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. |
| Measure Participants | 72 |
| Measure eyes | 143 |
| Within 0.50 D |
97
|
| Within 1.00 D |
129
|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| 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. |
| Measure Participants | 70 |
| Measure eyes | 139 |
| Count of Units [eyes] |
135
|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| 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. |
| Measure Participants | 70 |
| Measure eyes | 139 |
| Mean (Standard Deviation) [diopter] |
0.12
(0.40)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 32 sphere eyes assessed for this outcome measure. |
| Arm/Group Title | Technolas 217z Zyoptix System |
|---|---|
| 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. |
| Measure Participants | 16 |
| Measure eyes | 32 |
| Count of Units [eyes] |
0
|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| 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. |
| Measure Participants | 78 |
| Measure eyes | 155 |
| 12 months |
1
|
| 24 months |
3
|
Adverse Events
| 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 | |
| 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 (%) | # Events | |
| Total | 0/80 (0%) | |
Serious Adverse Events |
||
| Technolas 217z Zyoptix System | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/80 (1.3%) | |
| Injury, poisoning and procedural complications | ||
| Suction break | 1/80 (1.3%) | |
Other (Not Including Serious) Adverse Events |
||
| Technolas 217z Zyoptix System | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/80 (0%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Contact sponsor directly for details.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Bausch Health |
| Phone | 908-300-9920 |
| susan.harris@bauschhealth.com |
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00348205
Other Study ID Numbers:
- 369
First Posted:
Jul 4, 2006
Last Update Posted:
Sep 14, 2020
Last Verified:
Sep 1, 2020