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The purpose of this study is to evaluate the safety and effectiveness of the Bausch & Lomb Technolas 217z laser with the investigational Zyoptix Aspheric Algorithm when used for LASIK treatment of myopia and myopic astigmatism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Technolas 217z Excimer Laser | Experimental | Bausch & Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bausch & Lomb 217z Excimer Laser | Device | LASIK correction of myopia and myopic astigmatism |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes With Uncorrected High Contrast Distance Visual Acuity of 20/40 or Better | 3 months | |
| Percentage of Eyes With Manifest Subjective Refraction (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). | 3 months |
| Preservation of Manifest Best Corrected High Contrast Distance Visual Acuity | 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. | Baseline, 3 months |
| Percentage of Eyes With Manifest Best-corrected Distance Photopic Visual Acuity Decrease of 2 or More Lines | 3 months | |
| Percentage of Eyes With > 2.00 Diopter of Induced Postoperative Refractive Cylinder | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Higher Order Aberrations. | The aberrations in the eye's optical system were measured over the entire pupil by the Bausch & Lomb Zywave II WaveFront Aberrometer, a Hartmann-Shack type device. The pupil should have been at least 6 mm in diameter using 2.5% phenylephrine as a dilating agent to maximize the pupil diameter and hence the amount of wavefront information collected by the Zywave II. The wavefront data was then fitted with Zernike polynomials representing the 2nd, 3rd, 4th and 5th order Zernike terms. These terms represent the wavefront aberration of the eye. |
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Inclusion Criteria:
(Manifest subjective refractions adjusted for optical infinity were used.)
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Mark Cohen, MD | Lasik MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lasik MD, 130 King Street | Toronto | Ontario | M5X1C8 | Canada |
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Seventy two myopic participants (144 eyes) were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Technolas 217z Excimer Laser | Bausch & Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism. Bausch & Lomb 217z Excimer Laser: LASIK correction of myopia and myopic astigmatism |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants receiving treatment and demographic data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Technolas 217z Excimer Laser | Bausch & Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism. Bausch & Lomb 217z Excimer Laser: LASIK correction of myopia and myopic astigmatism |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 High Contrast Distance Visual Acuity of 20/40 or Better | There were 59 participants with visual acuity data available for analysis. | Posted | Number | 95% Confidence Interval | percentage of eyes | 3 months | eyes | eyes |
|
|
6 months
There were 66 treated participants evaluated for adverse events.
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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 Excimer Laser | Bausch & Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism. Bausch & Lomb 217z Excimer Laser: LASIK correction of myopia and myopic astigmatism |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bowman's membrane disorder | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch & Lomb Incorporated | 9083009926 | susan.harris@bauschhealth.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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This was a medical device study with only one intervention used for lasik correction surgery
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| 3 months |
| Percentage of Eyes That Had High Contrast Best Spectacle Corrected Visual Acuity (HCBSCVA) of 20/20 or Better at Baseline Had a Visual Outcome Worse Than 20/40 at 3 Months | 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. | 3 months |
| Baseline, 3 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| eyes |
|
|
| Primary | Percentage of Eyes With Manifest Subjective Refraction (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). | Posted | Count of Units | eyes | 3 months | eyes | eyes |
|
|
|
| Primary | Preservation of Manifest Best Corrected High Contrast Distance Visual Acuity | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 months | eyes | eyes |
|
|
|
| Primary | Percentage of Eyes With Manifest Best-corrected Distance Photopic Visual Acuity Decrease of 2 or More Lines | Posted | Count of Units | eyes | 3 months | eyes | eyes |
|
|
|
| Primary | Percentage of Eyes With > 2.00 Diopter of Induced Postoperative Refractive Cylinder | 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). | Posted | Count of Units | eyes | 3 months | eyes | eyes |
|
|
|
| Primary | Percentage of Eyes That Had High Contrast Best Spectacle Corrected Visual Acuity (HCBSCVA) of 20/20 or Better at Baseline Had a Visual Outcome Worse Than 20/40 at 3 Months | 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. | Posted | Count of Units | eyes | 3 months | eyes | eyes |
|
|
|
| Secondary | Percentage Change From Baseline in Higher Order Aberrations. | The aberrations in the eye's optical system were measured over the entire pupil by the Bausch & Lomb Zywave II WaveFront Aberrometer, a Hartmann-Shack type device. The pupil should have been at least 6 mm in diameter using 2.5% phenylephrine as a dilating agent to maximize the pupil diameter and hence the amount of wavefront information collected by the Zywave II. The wavefront data was then fitted with Zernike polynomials representing the 2nd, 3rd, 4th and 5th order Zernike terms. These terms represent the wavefront aberration of the eye. | Posted | Mean | Standard Deviation | Percentage change | Baseline, 3 months | eyes | eyes |
|
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| 51 |
| 66 |
| Corneal edema | Eye disorders | Non-systematic Assessment |
|
| Keratitis | Eye disorders | Non-systematic Assessment |
|
| Punctate keratitis | Eye disorders | Non-systematic Assessment |
|
| Eye operation complication | Eye disorders | Non-systematic Assessment |
|
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