Hyperopia
Conditions
Keywords
refractive, errors
Brief summary
Demonstrate that wavefront-guided LASIK using measurements from the iDesign System is safe and effective for the treatment of Hyperopia.
Interventions
DEVICELASIK correction of hyperopic 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
* 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 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 | Description |
|---|---|---|
| Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA) | 12 Months | Hypothesis: \<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 |
|---|---|---|
| Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better | 12 Months | Hypothesis: 85% of eyes will have uncorrected visual acuity of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters |
Countries
United States
Participant flow
Pre-assignment details
167 subjects were consented in the study, of which 69 subjects had one or both eyes treated for a total of 135 treated eyes.
Participants by arm
| Arm | Count |
|---|---|
| Wavefront-Guided LASIK LASIK : Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System for correction of hyperopic refractive errors | 69 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 11 |
Baseline characteristics
| Characteristic | Wavefront-Guided LASIK |
|---|---|
| Age, Continuous | 42.7 years STANDARD_DEVIATION 11.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 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 | 6 Participants |
| Race (NIH/OMB) White | 58 Participants |
| Region of Enrollment United States | 69 Participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 69 |
| other Total, other adverse events | 0 / 69 |
| serious Total, serious adverse events | 3 / 69 |
Outcome results
Primary
Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA)
Hypothesis: \<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: 12 Months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Wavefront-Guided LASIK | Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA) | 2 eyes |
Secondary
Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better
Hypothesis: 85% of eyes will have uncorrected visual acuity of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Wavefront-Guided LASIK | Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better | 123 eyes |