Astigmatism, Myopia
Conditions
Brief summary
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.
Interventions
DEVICEBausch & Lomb 217z Excimer Laser
LASIK correction of myopia and myopic astigmatism
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This was a medical device study with only one intervention used for lasik correction surgery
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who were of legal age (at least 18) and had full legal capacity to volunteer. * Subjects must be willing to have both eyes treated with the laser. * Subjects must have up to -12.00D of absolute spherical myopia (not spherical equivalent) with up to -6.00D of refractive astigmatism, with a spherical equivalent up to -15.00D as measured by manifest subjective refraction. * Subjects who had less than 0.75 D of difference in the preoperative manifest spherical equivalent and cycloplegic spherical equivalent subjective refractions. (Manifest subjective refractions adjusted for optical infinity were used.) * High contrast, manifest best spectacle-corrected distance logMAR visual acuity correctable to at least 0.3 in both eyes, and must not differ between eyes by more than 1 line (5 letters). * Contact lens wearers must have 2 Orbscan measurements and 2 manifest subjective refractions taken preoperatively at least 1 week apart. * Contact lens wearers must have gas permeable lenses discontinued for at least 3 weeks and soft lenses discontinued for at least 2 weeks prior to the preoperative evaluation. Exclusion * Subjects with uncorrected visual acuity better than 20/40 (Snellen) or 0.3 logMAR * Subjects who were immuno-compromised or had a diagnosis of connective tissue disease, clinically significant atopic disease, diabetes, autoimmune diseases and other acute or chronic illnesses that increased the risk to the subject or could have confounded the outcomes of this study. * Subjects with uncontrolled glaucoma or glaucoma who were under treatment in the study eye or with ocular hypertension. * Subjects who demonstrated evidence of retinal vascular disease. * Subjects who have an ocular muscle disorder including strabismus or nystagmus, or other disorders that affected fixation. * Subjects who were at risk for angle closure or who had a potentially occludable angle, as evidenced by a shallow anterior chamber on slit lamp exam, confirmed by gonioscopy as deemed necessary by the study Investigator. * Subjects who had undergone previous intraocular or corneal surgery of any kind, including any type of excimer laser surgery for either refractive or therapeutic purposes. * Subjects who were taking systemic medications likely to affect wound healing such as corticosteroids or anti-metabolites or any other medications that may increase the risk to the subject or confound the outcomes of this study. * Subjects for whom the combination of their preoperative corneal thickness and the planned operative parameters for the LASIK procedure could have resulted in less than 250 microns of remaining posterior corneal thickness below the flap postoperatively.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preservation of Manifest Best Corrected High Contrast Distance Visual Acuity | Baseline, 3 months | 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. |
| 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 | 3 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 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 | 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. |
| 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 | 3 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Higher Order Aberrations. | Baseline, 3 months | 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. |
Countries
Canada
Participant flow
Recruitment details
Seventy two myopic participants (144 eyes) were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | Technolas 217z Excimer Laser |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 65 Participants |
| Age, Continuous | 32.0 years STANDARD_DEVIATION 7.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 21 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 66 |
| other Total, other adverse events | 51 / 66 |
| serious Total, serious adverse events | 0 / 66 |
Outcome results
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.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Technolas 217z Excimer Laser | 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 | 0 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).
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Technolas 217z Excimer Laser | Percentage of Eyes With > 2.00 Diopter of Induced Postoperative Refractive Cylinder | 0 eyes |
Primary
Percentage of Eyes With Manifest Best-corrected Distance Photopic Visual Acuity Decrease of 2 or More Lines
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Technolas 217z Excimer Laser | Percentage of Eyes With Manifest Best-corrected Distance Photopic Visual Acuity Decrease of 2 or More Lines | 1 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).
Time frame: 3 months
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Technolas 217z Excimer Laser | Percentage of Eyes With Manifest Subjective Refraction (MRSE) Within ± 1.00 Diopter (D) and 0.50 D of Emmetropia | Within 0.50 D | 109 eyes |
| Technolas 217z Excimer Laser | Percentage of Eyes With Manifest Subjective Refraction (MRSE) Within ± 1.00 Diopter (D) and 0.50 D of Emmetropia | Within 1.00 D | 117 eyes |
Primary
Percentage of Eyes With Uncorrected High Contrast Distance Visual Acuity of 20/40 or Better
Time frame: 3 months
Population: There were 59 participants with visual acuity data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Technolas 217z Excimer Laser | Percentage of Eyes With Uncorrected High Contrast Distance Visual Acuity of 20/40 or Better | 99.2 percentage of 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.
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Technolas 217z Excimer Laser | Preservation of Manifest Best Corrected High Contrast Distance Visual Acuity | -0.055 units on a scale | Standard Deviation 0.103 |
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.
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Technolas 217z Excimer Laser | Percentage Change From Baseline in Higher Order Aberrations. | 24.9 Percentage change | Standard Deviation 0.1413 |