Astigmatism
Conditions
Keywords
Astigmatism, refractive, error, LASIK
Brief summary
To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.
Interventions
DEVICELASIK
Surgeons will perform wavefront-guided LASIK based upon measurements 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
* At least 18 years of age at the time of pre-operative exam * Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better * Demonstration of refractive stability * Anticipated post-operative stromal bed thickness of at lest 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 | Description |
|---|---|---|
| Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA) | 3 Months | \< 5% of eyes will have a loss of \> 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Visual Acuity (UCVA) of 20/40 or Better | 3 Months | 85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Wave-front Guided LASIK LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction | 84 |
| Wave-front Guided LASIK LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction | 149 |
| Total | 233 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | study completed early - product approval | 42 |
Baseline characteristics
| Characteristic | Wave-front Guided LASIK |
|---|---|
| Age, Continuous | 36.3 years STANDARD_DEVIATION 10.36 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 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 | 3 Participants |
| Race (NIH/OMB) White | 73 Participants |
| Region of Enrollment United States | 84 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 84 |
| other Total, other adverse events | 0 / 84 |
| serious Total, serious adverse events | 0 / 84 |
Outcome results
Primary
Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA)
\< 5% of eyes will have a loss of \> 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters
Time frame: 3 Months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Wave-front Guided LASIK | Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA) | 149 eyes |
Secondary
Uncorrected Visual Acuity (UCVA) of 20/40 or Better
85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters
Time frame: 3 Months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Wave-front Guided LASIK | Uncorrected Visual Acuity (UCVA) of 20/40 or Better | 149 eyes |