An interventional study of Technolas 217z Zyoptix Laser in Hyperopia and Astigmatism, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-14.
Sponsored by Bausch & Lomb Incorporated · Not applicable, Interventional, and Treatment
A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery treatments for hyperopia and astigmatism.
413 studies on the registry are indexed under Astigmatism; 55 are open to participants now.
This study's enrollment of 80 is above the median of 55 across 321 interventional studies indexed under Astigmatism.
Browse Astigmatism studies →Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 41 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
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
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).
Time frame: 24 months
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).
Time frame: Month 1, Month 3
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).
Time frame: 1 month, 3 months
Induced Astigmatism
Percentage of eyes which had \>2.00 Diopter of induced refractive cylinder for those eyes treated for spherical hyperopia only.
Time frame: 24 months
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.
Time frame: 24 months
| Milestone | Technolas 217z Zyoptix System |
|---|---|
| Started | 80 |
| Completed | 78 |
| Not completed | 2 |
| eyes | Technolas 217z Zyoptix System |
|---|---|
| 12 months | 147 |
| 24 months | 140 |
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).
| eyes | Technolas 217z Zyoptix System |
|---|---|
| Within 0.50 D | 100 |
| Within 1.00 D | 142 |
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).
| eyes | Technolas 217z Zyoptix System |
|---|---|
| Within 0.50 D | 97 |
| Within 1.00 D | 129 |
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).
| eyes | Technolas 217z Zyoptix System |
|---|---|
| Refractive Stability - Categorical Change Between Month 1 and Month 3 | 135 |
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).
| diopter | Technolas 217z Zyoptix System |
|---|---|
| Refractive Stability - Mean Change Between Month 1 and Month 3 | 0.12 ± 0.40 |
Percentage of eyes which had \>2.00 Diopter of induced refractive cylinder for those eyes treated for spherical hyperopia only.
| eyes | Technolas 217z Zyoptix System |
|---|---|
| Induced Astigmatism | 0 |
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.
| eyes | Technolas 217z Zyoptix System |
|---|---|
| 12 months | 1 |
| 24 months | 3 |
Collected over 24 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Technolas 217z Zyoptix System | 0/80 (0%) | 1/80 (1.3%) | 0/80 (0%) |
| Event | Technolas 217z Zyoptix System |
|---|---|
| Suction breakInjury, poisoning and procedural complications | 1/80 |
| Age, Continuous(years) | Technolas 217z Zyoptix System |
|---|---|
| Mean | 49.5 ± 8.7 |
| Sex: Female, Male(Participants) | Technolas 217z Zyoptix System |
|---|---|
| Female | 45 |
| Male | 35 |
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Bausch & Lomb Incorporated