Myopia
Conditions
Keywords
refractive, LASIK
Brief summary
The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and effective for the correction of myopic refractive errors.
Interventions
DEVICELASIK correction of myopic refractive errors
Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
Sponsors
Abbott Medical Optics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or greater * Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better * Uncorrected visual acuity (UCVA) of 20/40 or worse * Less than 0.75D difference between cycloplegic and manifest refraction sphere. * Demonstration of refractive stability * Anticipated post-operative stromal bed thickness of at least 250 microns * 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 * Concurrent use of topical or systemic medications that may impair healing * History of any medical conditions that could affect wound healing * History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality * Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s) * Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) | 6 Months |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better | 6 Months |
Participant flow
Recruitment details
334 eyes were treated among 170 participants.
Participants by arm
| Arm | Count |
|---|---|
| Wavefront-guided LASIK LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System | 170 |
| Total | 170 |
Baseline characteristics
| Characteristic | Wavefront-guided LASIK |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 169 Participants |
| Region of Enrollment United States | 170 participants |
| Sex: Female, Male Female | 77 Participants |
| Sex: Female, Male Male | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 334 |
| serious Total, serious adverse events | 5 / 334 |
Outcome results
Primary
Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)
Time frame: 6 Months
Population: Data from 334 eyes of 170 participants are included for the outcome measure Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Wavefront-guided LASIK | Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) | 0 percentage of eyes |
Secondary
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better
Time frame: 6 Months
Population: Percentage of eyes with UCVA of 20/40 or better. Target for this outcome measure is greater than 85% achieving UCVA of 20/40 or Better. Data from 334 eyes of 170 participants are included for the outcome measure Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Wavefront-guided LASIK | Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better | 98.2 percentage of eyes |