Refractive Error
Conditions
Brief summary
The results of this trial will demonstrate that the iDesign System 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 iDesign Aberrometer
CustomVue LASIK 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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, of any race, and at least 18 years old at the time the consent form is signed. * The refractive error, based on manifest refraction (adjusted for optical infinity), must be MRSE up to -15.00 D with manifest cylinder between 0.00 and -6.00 D; MRSE up to +9.00 D with cylinder between 0.00 and +6.00 D; or manifest cylinder (from 1.00 to 6.00 D) greater than the magnitude of sphere, and the cylinder and sphere have opposite signs. * BSCVA of 20/20 or better. * UCVA: * Myopes must be 20/40 or worse. * Subjects with Hyperopia or mixed astigmatism, treatment may be based on difficulty maintaining UCVA of 20/40 evidenced by spectacle/contact lens dependence for distance, as documented by the investigator. * Wavefront diameter ≥ 4.0 mm. * Sufficient agreement between manifest refraction (adjusted for optical infinity) and iDesign System refraction (sphere, cylinder, and axis) to allow treatment selection and generation of an ablation profile as determined by the investigational iDesign System software. * Manifest refraction sphere within ± 0.75 D of cycloplegic refraction sphere. * 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 (as calculated by the iDesign System) and the intended flap thickness. * Anticipated post-operative keratometry value (based on pre-operative iDesign System refraction and keratometry) that is appropriate. * A stable refractive error (based on a previous exam, medical records, or prescription) as compared to the unadjusted pre-operative manifest refraction. * Subjects who currently wear contact lenses must demonstrate refractive stability in the operative eye. Rigid or toric lenses must be removed for at least 2 weeks and SCL for at least 3 days prior to the first refraction used to establish stability. A second refraction with a change of no more than ± 0.50 D MRSE at least 7 days after baseline. * Willing and capable of returning for follow-up examinations for the duration of the study.
Exclusion criteria
* Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study, as determined by verbal inquiry, or another condition associated with the fluctuation of hormones that could lead to refractive changes. * Subjects with an ametropic or amblyopic fellow eye not meeting all inclusion criteria that does not fall within the indications for treatment using the VISX® STAR S4 IR™ Excimer Laser. * Concurrent use of systemic (including inhaled) medications that may impair healing, including but not limited to: steroids, antimetabolites, isotretinoin (Accutane™) within 6 months of treatment, and amiodarone hydrochloride (Cordarone™) within 12 months of treatment. * Acute or chronic disease, illness, or treatment that would increase the operative risk (e.g., immuno-compromised, autoimmune disease, connective tissue disease, clinically significant atopic disease, diabetes, etc.). * Subjects with a cardiac pacemaker, implanted defibrillator, implanted neurostimulator, or any active electrical implants. * Ocular condition (other than high myopia) that may predispose the subject to future complications, such as history or evidence of active or inactive corneal disease * Previous intraocular or corneal surgery that might confound the outcome of the study or increase risk to the subject. * Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course. * Concurrent participation in any other clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better. | 6 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With Manifest Refraction Spherical Equivalent Within 1.0 D | 6 months | — |
| Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) | 6 Months | — |
| Percentage of Eyes With Best Spectacle Corrected Visual Acuity (BSCVA) Worse Than 20/40 | 6 Months | — |
| Percentage of Eyes With Induced Manifest Refractive Astigmatism Greater Than 2.00 D of Absolute Cylinder as Compared to the Preoperative Refraction | 6 Months | Induced Manifest Refractive Astigmatism is an increase of astigmatism (cylinder) postoperatively that could be caused by the refractive treatment. An increase of greater than 2.0 D is considered a safety endpoint per ANSI Z80.11-2007. |
Countries
Canada
Participant flow
Recruitment details
One or both eyes of 77 subjects (143 eyes) were treated. This includes a predominance of Caucasian participants and a mean age of 37.2 years.
Participants by arm
| Arm | Count |
|---|---|
| Hyperopia With or Without Astigmatism Hyperopia with and without astigmatism with MRSE up to
+9.00 D, with cylinder between 0.00 and +6.00 D. | 11 |
| 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. | 56 |
| 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. | 10 |
| Total | 77 |
Baseline characteristics
| Characteristic | Hyperopia With or Without Astigmatism | Myopia With or 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 | 11 Participants | 56 Participants | 10 Participants | 77 Participants |
| Region of Enrollment Canada | 11 participants | 56 participants | 10 participants | 77 participants |
| Sex: Female, Male Female | 6 Participants | 28 Participants | 4 Participants | 38 Participants |
| Sex: Female, Male Male | 5 Participants | 28 Participants | 6 Participants | 39 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 | 2 / 11 | 4 / 56 | 0 / 10 |
| serious Total, serious adverse events | 1 / 11 | 2 / 56 | 0 / 10 |
Outcome results
Primary
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better.
Time frame: 6 months
Population: UCVA is reported as percentage of eyes not percentage of subjects achieving UCVA of 20/40 or better
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Myopia With and Without Astigmatism | Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better. | 100 percentage of eyes |
| Hyperopia With and Without Astigmatism | Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better. | 100 percentage of eyes |
| Mixed Astigmatism | Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better. | 100 percentage of eyes |
Other Pre-specified
Percentage of Eyes With Best Spectacle Corrected Visual Acuity (BSCVA) Worse Than 20/40
Time frame: 6 Months
Population: Percentage of eyes with BSCVA worse than 20/40
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Myopia With and Without Astigmatism | Percentage of Eyes With Best Spectacle Corrected Visual Acuity (BSCVA) Worse Than 20/40 | 0 percentage of eyes |
| Hyperopia With and Without Astigmatism | Percentage of Eyes With Best Spectacle Corrected Visual Acuity (BSCVA) Worse Than 20/40 | 0 percentage of eyes |
| Mixed Astigmatism | Percentage of Eyes With Best Spectacle Corrected Visual Acuity (BSCVA) Worse Than 20/40 | 0 percentage of eyes |
Other Pre-specified
Percentage of Eyes With Induced Manifest Refractive Astigmatism Greater Than 2.00 D of Absolute Cylinder as Compared to the Preoperative Refraction
Induced Manifest Refractive Astigmatism is an increase of astigmatism (cylinder) postoperatively that could be caused by the refractive treatment. An increase of greater than 2.0 D is considered a safety endpoint per ANSI Z80.11-2007.
Time frame: 6 Months
Population: Percentage of eyes with induced manifest refractive astigmatism greater than 2.00 D of absolute cylinder power
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Myopia With and Without Astigmatism | Percentage of Eyes With Induced Manifest Refractive Astigmatism Greater Than 2.00 D of Absolute Cylinder as Compared to the Preoperative Refraction | 0 percentage of eyes |
| Hyperopia With and Without Astigmatism | Percentage of Eyes With Induced Manifest Refractive Astigmatism Greater Than 2.00 D of Absolute Cylinder as Compared to the Preoperative Refraction | 0 percentage of eyes |
| Mixed Astigmatism | Percentage of Eyes With Induced Manifest Refractive Astigmatism Greater Than 2.00 D of Absolute Cylinder as Compared to the Preoperative Refraction | 0 percentage of eyes |
Other Pre-specified
Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)
Time frame: 6 Months
Population: Percent of eyes that lost more than 2 lines of BSCVA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Myopia With and Without Astigmatism | Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) | 0 percentage of eyes |
| Hyperopia With and Without Astigmatism | Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) | 5.3 percentage of eyes |
| Mixed Astigmatism | Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) | 0 percentage of eyes |
Other Pre-specified
Percentage of Eyes With Manifest Refraction Spherical Equivalent Within 1.0 D
Time frame: 6 months
Population: Percent of eyes that achieved manifest refraction spherical equivalent within 1.0 D
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Myopia With and Without Astigmatism | Percentage of Eyes With Manifest Refraction Spherical Equivalent Within 1.0 D | 99.1 percentage of eyes |
| Hyperopia With and Without Astigmatism | Percentage of Eyes With Manifest Refraction Spherical Equivalent Within 1.0 D | 89.5 percentage of eyes |
| Mixed Astigmatism | Percentage of Eyes With Manifest Refraction Spherical Equivalent Within 1.0 D | 93.8 percentage of eyes |