Stable Myopic Refractive Error, With or Without Astigmatism
Conditions
Keywords
myopia
Brief summary
Prospective, multicenter, bilaterally-treated, open-label, non-randomized clinical trial.
Interventions
DEVICESTAR S4 IR laser with iDesign
Surgeons will perform wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser.
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
No
Inclusion criteria
NOTE: Enrollment open only to military personnel Inclusion Criteria: * Signed informed consent and HIPAA authorization. * Refractive error, based on the iDesign displayed refraction must be myopia with or without astigmatism with sphere up to -8.00 D, and cylinder between 0.00 D and -4.00 D with maximum SE of -10.00 D. * Anticipated residual stromal bed thickness of at least 250 microns as calculated by the iDesign system. * Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better * BSCVA ≥2 lines (≥10 letters) better than distance Uncorrected Visual Acuity (UCVA). * Less than or equal to 0.75 D difference between cycloplegic and manifest refraction sphere. * Stable refractive error as defined by a change of ≤1.00 D in MRSE over at least a 12 month time period. * Any subject eye with a history of contact lens wear within the last 4 weeks must demonstrate refractive stability * Agreement between manifest refraction (adjusted for optical infinity) and iDesign System refraction chosen for treatment. * Willing and capable of complying with follow-up examinations for the duration of the study.
Exclusion criteria
* Women who are pregnant, breast-feeding, or intend to become pregnant, or not using an adequate method of birth control. * Concurrent use of systemic (including inhaled) medications that may impair healing. * 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, implanted defibrillator or other implanted electronic device. * History of prior intraocular or corneal surgery, active ophthalmic disease or abnormality, retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm and visible on topography, 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 topography * Known sensitivity or inappropriate responsiveness to any of the medications used in this study. * If either eye does not meet all inclusion criteria * Desire to have monovision. * Participation in any other clinical study, with the exception of the fellow eye in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Eyes Achieving the Target of Monocular Uncorrected Visual Acuity of 20/40 or Better | 6 months | At 6 months, UCVA of 20/40 was achieved in 100% (324/324) of eyes monocularly. |
Participant flow
Pre-assignment details
235 subjects were consented in the study, of which all 167 subjects have both eyes treated for a total of 334 treated eyes.
Participants by arm
| Arm | Count |
|---|---|
| PRK Correction With iDesign System and STAR S4 IR Laser Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser | 167 |
| PRK Correction With iDesign System and STAR S4 IR Laser Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser | 334 |
| Total | 501 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 16 |
Baseline characteristics
| Characteristic | PRK Correction With iDesign System and STAR S4 IR Laser |
|---|---|
| Age, Continuous | 26.6 Years STANDARD_DEVIATION 5.41 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 12 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants |
| Race (NIH/OMB) More than one race | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 110 Participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 167 |
| other Total, other adverse events | 0 / 167 |
| serious Total, serious adverse events | 10 / 167 |
Outcome results
Primary
The Percentage of Eyes Achieving the Target of Monocular Uncorrected Visual Acuity of 20/40 or Better
At 6 months, UCVA of 20/40 was achieved in 100% (324/324) of eyes monocularly.
Time frame: 6 months
Population: Of the 334 eyes (167 subjects) treated in the study, 324 eyes (162 subjects) were available at 6 months for analysis.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| PRK Correction With iDesign System and STAR S4 IR Laser | The Percentage of Eyes Achieving the Target of Monocular Uncorrected Visual Acuity of 20/40 or Better | 324 Eyes |