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A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery treatments for hyperopia and astigmatism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Technolas 217z Zyoptix System | Experimental | Bausch & Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technolas 217z Zyoptix Laser | Device | Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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). | 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). | Month 1, Month 3 |
| Refractive Stability - Mean Change Between Month 1 and Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb | Rochester | New York | 14609 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months | The number of eyes available for uncorrected visual acuity assessment at 12 months and 24 months were included in the analysis. | Posted | Count of Units | eyes | 24 months | eyes | eyes |
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24 months
Adverse events (AEs) were assessed throughout the study. AEs were not coded (therefore, there is no source vocabulary).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suction break | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | 908-300-9920 | susan.harris@bauschhealth.com |
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| ID | Term |
|---|---|
| D006956 | Hyperopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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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). |
| 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. | 24 months |
| 24 months |
| eyes |
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| years |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Participants |
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| eyes |
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| 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). | The number of eyes available for manifest refraction spherical equivalent assessment at 12 months were included in the analysis. | Posted | Count of Units | eyes | 12 months | eyes | eyes |
|
|
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| 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). | The number of eyes available for manifest refraction spherical equivalent assessment at 24 months were included in the analysis. | Posted | Count of Units | eyes | 24 months | eyes | eyes |
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| 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). | There were 139 eyes with manifest refraction spherical equivalent assessments at both Month 1 and Month 3 for this outcome assessment. | Posted | Count of Units | eyes | Month 1, Month 3 | eyes | eyes |
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| 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). | There were 139 eyes with manifest refraction spherical equivalent assessments at both Month 1 and Month 3 for this outcome assessment. | Posted | Mean | Standard Deviation | diopter | 1 month, 3 months | eyes | eyes |
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| Primary | Induced Astigmatism | Percentage of eyes which had >2.00 Diopter of induced refractive cylinder for those eyes treated for spherical hyperopia only. | There were 32 sphere eyes assessed for this outcome measure. | Posted | Count of Units | eyes | 24 months | eyes | eyes |
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| 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. | The number of eyes available for uncorrected visual acuity assessment at 12 months and 24 months were included in the analysis. | Posted | Count of Units | eyes | 24 months | eyes | eyes |
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| 80 |
| 1 |
| 80 |
| 0 |
| 80 |
Contact sponsor directly for details.
| 24 months |
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