Astigmatism, Hyperopia
Conditions
Brief summary
A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery treatments for hyperopia and astigmatism.
Interventions
DEVICETechnolas 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.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hyperopia with or without astigmatism.
Exclusion criteria
* Contraindications to LASIK.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| Induced Astigmatism | 24 months | Percentage of eyes which had \>2.00 Diopter of induced refractive cylinder for those eyes treated for spherical hyperopia only. |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Technolas 217z Zyoptix System 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. | 80 |
| Technolas 217z Zyoptix System 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. | 159 |
| Total | 239 |
Baseline characteristics
| Characteristic | Technolas 217z Zyoptix System |
|---|---|
| Age, Continuous | 49.5 years STANDARD_DEVIATION 8.7 |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 80 |
| other Total, other adverse events | 0 / 80 |
| serious Total, serious adverse events | 1 / 80 |
Outcome results
Primary
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
Population: There were 32 sphere eyes assessed for this outcome measure.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Technolas 217z Zyoptix System | Induced Astigmatism | 0 eyes |
Primary
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
Population: The number of eyes available for manifest refraction spherical equivalent assessment at 12 months were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Technolas 217z Zyoptix System | Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia. | Within 0.50 D | 100 eyes |
| Technolas 217z Zyoptix System | Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia. | Within 1.00 D | 142 eyes |
Primary
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months
Time frame: 24 months
Population: The number of eyes available for uncorrected visual acuity assessment at 12 months and 24 months were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Technolas 217z Zyoptix System | Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months | 12 months | 147 eyes |
| Technolas 217z Zyoptix System | Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months | 24 months | 140 eyes |
Primary
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
Population: There were 139 eyes with manifest refraction spherical equivalent assessments at both Month 1 and Month 3 for this outcome assessment.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Technolas 217z Zyoptix System | Refractive Stability - Categorical Change Between Month 1 and Month 3 | 135 eyes |
Primary
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
Population: There were 139 eyes with manifest refraction spherical equivalent assessments at both Month 1 and Month 3 for this outcome assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Technolas 217z Zyoptix System | Refractive Stability - Mean Change Between Month 1 and Month 3 | 0.12 diopter | Standard Deviation 0.4 |
Primary
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
Population: The number of eyes available for manifest refraction spherical equivalent assessment at 24 months were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Technolas 217z Zyoptix System | The Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia | Within 0.50 D | 97 eyes |
| Technolas 217z Zyoptix System | The Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia | Within 1.00 D | 129 eyes |
Secondary
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
Population: The number of eyes available for uncorrected visual acuity assessment at 12 months and 24 months were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Technolas 217z Zyoptix System | Loss of Best Spectacle-corrected Visual Acuity (BSCVA) | 12 months | 1 eyes |
| Technolas 217z Zyoptix System | Loss of Best Spectacle-corrected Visual Acuity (BSCVA) | 24 months | 3 eyes |