Refractive Error
Conditions
Brief summary
The results of this trial will demonstrate that AVSS software performs as intended and is acceptable in a clinical setting.
Detailed description
LASIK treatment across the range of myopia with or without astigmatism, hyperopia with or without astigmatism, and mixed astigmatism.
Interventions
DEVICESTAR S4IR LASIK with VSS-R ablation profile
LASIK treatment targeted for emmetropia
Sponsors
Abbott Medical Optics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, of any race, and at least 21 years old at the time of the pre-operative examination and signing the consent form. * The refractive error, based on manifest refraction at the spectacle plane, of: MRSE up to -15.00 D with manifest cylinder between 0.00 and -6.00 D; MRSE up to +7.00 D, with manifest cylinder between 0.00 and 6.00 D; or Manifest cylinder (from 1.0 to 6.0 D) greater than the magnitude of sphere, and the manifest cylinder and sphere have opposite signs. * BSCVA of 20/20 or better. * UCVA of 20/40 or worse. * Manifest refraction sphere within ± 0.75 D of cycloplegic refraction sphere (at the same vertex distance). * Anticipated post-operative stromal bed thickness of at least 250 microns, based on pre-operative central corneal pachymetry minus the maximum treatment depth to be ablated and the intended flap thickness, and confirmed by intra-operative central corneal pachymetry. * Anticipated post-operative keratometry value (based on pre-operative manifest refraction and keratometry) that is appropriate. * A stable refractive error, based on an exam (or prescription) at least 12 months prior to the pre-operative examination and as compared to the pre-operative manifest refraction * Subjects who have worn a contact lens in the operative eye must discontinue lens wear at least three (3) consecutive weeks prior to the pre-operative examination. If, upon review of pre-operative measurements, the Investigator determines that the corneal topography is within normal limits, surgery may be scheduled (within 60 days), with no contact lens wear permitted prior to the surgery. * Willing and capable of returning for follow-up examinations for the duration of the study (6 months).
Exclusion criteria
* Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study, as determined by verbal inquiry. * Concurrent use of topical or systemic medications that may impair healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment. * History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis. * Subjects with a cardiac pacemaker or implanted defibrillator. * History of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, symptomatic blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization \> 1mm from limbus), retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm, at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma. * Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal videokeratography. * Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course. * Subjects with one eye that does not meet all inclusion criteria and does not fall within approved indications for treatment using the VISX® STAR S4 IR® Excimer Laser. * Participation in any other clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better | 1 Year |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percent Manifest Refraction Spherical Equivalent Within 1.0D | 1 Year | Manifest refraction spherical equivalent is the required spectacle (or glass) prescription. |
| Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) | 1 Year | After surgery, with or without best spectacle prescription the subject is not expected to see worse than before surgery. As a metric for this safety endpoint, losses of 2 lines of vision on a standard eye chart, with best spectacle correction, after surgery compared to pre-operative baseline shall be evaluated. For example 20/20 is typically considered best vision and 2 lines worse than this will be 20/32). |
| Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power | 1 Year | — |
Countries
Canada
Participant flow
Recruitment details
One or both eyes of 79 subjects (150 eyes) were treated.
Participants by arm
| Arm | Count |
|---|---|
| Myopia With or Without Astigmatism Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D. | 57 |
| Hyperopia With and Without Astigmatism Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D. | 13 |
| Mixed Astigmatism Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs. | 9 |
| Total | 79 |
Baseline characteristics
| Characteristic | Myopia With or Without Astigmatism | Hyperopia With and Without Astigmatism | Mixed Astigmatism | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants | 13 Participants | 9 Participants | 79 Participants |
| Region of Enrollment Canada | 57 participants | 13 participants | 9 participants | 79 participants |
| Sex: Female, Male Female | 25 Participants | 9 Participants | 4 Participants | 38 Participants |
| Sex: Female, Male Male | 32 Participants | 4 Participants | 5 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 57 | 12 / 13 | 0 / 9 |
| serious Total, serious adverse events | 0 / 57 | 1 / 13 | 0 / 9 |
Outcome results
Primary
Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better
Time frame: 1 Year
Population: As a measure of effectiveness of LASIK treatment with VSS, distance visual performance without spectacles, clinically measured as Uncorrected Visual Acuity (UCVA) will be measured under standardized conditions such as 4 meter testing distance, controlled ambient room lighting and standard eye charts.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Myopia With and Without Astigmatism | Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better | 99.1 percentage of eyes |
| Hyperopia With and Without Astigmatism | Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better | 96.0 percentage of eyes |
| Mixed Astigmatism | Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better | 100.0 percentage of eyes |
Other Pre-specified
Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power
Time frame: 1 Year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Myopia With and Without Astigmatism | Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power | 0.0 percentage of eyes |
| Hyperopia With and Without Astigmatism | Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power | 0.0 percentage of eyes |
| Mixed Astigmatism | Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power | 0.0 percentage of eyes |
Other Pre-specified
Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)
After surgery, with or without best spectacle prescription the subject is not expected to see worse than before surgery. As a metric for this safety endpoint, losses of 2 lines of vision on a standard eye chart, with best spectacle correction, after surgery compared to pre-operative baseline shall be evaluated. For example 20/20 is typically considered best vision and 2 lines worse than this will be 20/32).
Time frame: 1 Year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Myopia With and Without Astigmatism | Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) | .9 percentage of eyes |
| Hyperopia With and Without Astigmatism | Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) | 4.0 percentage of eyes |
| Mixed Astigmatism | Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) | 0.0 percentage of eyes |
Other Pre-specified
Percent Manifest Refraction Spherical Equivalent Within 1.0D
Manifest refraction spherical equivalent is the required spectacle (or glass) prescription.
Time frame: 1 Year
Population: As a measure of effectiveness of LASIK treatment with VSS, the required spectacle prescription, also called manifest refraction, will be measured under standardized conditions such as 4 meter testing distance, controlled ambient room lighting and standard eye charts.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Myopia With and Without Astigmatism | Percent Manifest Refraction Spherical Equivalent Within 1.0D | 96.4 percentage of eyes |
| Hyperopia With and Without Astigmatism | Percent Manifest Refraction Spherical Equivalent Within 1.0D | 92.0 percentage of eyes |
| Mixed Astigmatism | Percent Manifest Refraction Spherical Equivalent Within 1.0D | 100.0 percentage of eyes |