A Phase 3 interventional study of LASIK correction of myopic refractive errors in Myopia, sponsored by Abbott Medical Optics. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Abbott Medical Optics · Phase 3, Interventional, and Treatment
The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and effective for the correction of myopic refractive errors.
413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.
This study's enrollment of 170 is above the median of 82 across 296 interventional studies indexed under Refractive Errors.
Browse Refractive Errors studies →Abbott Medical Optics is the lead sponsor of 34 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
LASIK correction of myopic refractive errors. Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
Device: LASIK correction of myopic refractive errors
Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)
Time frame: 6 Months
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better
Time frame: 6 Months
334 eyes were treated among 170 participants.
| Milestone | Wavefront-guided LASIK |
|---|---|
| Started | 170 |
| Completed | 170 |
| Not completed | 0 |
| percentage of eyes | Wavefront-guided LASIK |
|---|---|
| Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) | 0 (NA to NA) |
| percentage of eyes | Wavefront-guided LASIK |
|---|---|
| Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better | 98.2 (96.1 to 99.3) |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Wavefront-guided LASIK | — | 5/334 (1.5%) | 0/334 (0%) |
| Event | Wavefront-guided LASIK |
|---|---|
| Primary open angle glaucomaEye disorders | 2/334 |
| Transient light sensitivity syndromeEye disorders | 2/334 |
| Melting of the flapEye disorders | 1/334 |
The number of participants is 170, but 334 eyes were evaluated among these 170 participants.
| Age, Categorical(Participants) | Wavefront-guided LASIK |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 169 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Wavefront-guided LASIK |
|---|---|
| Female | 77 |
| Male | 93 |
| Region of Enrollment(participants) | Wavefront-guided LASIK |
|---|---|
| United States | 170 |
No study locations are listed for this record.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Abbott Medical Optics