Astigmatism, Myopia
Conditions
Brief summary
The purpose of this clinical trial is to demonstrate that treatments generated by an investigational algorithm reduces spherical aberration compared to currently available iDesign treatments.
Detailed description
Post-LASIK induction of spherical aberration is currently among the most prominent challenges for refractive surgery. The presence of significant spherical aberration in the visual system results in reduced contrast sensitivity, visual symptoms such as glare and halos, and night myopia or the induction of myopia under low lighting (larger pupil size). A modified Treatment Planning Software (TPS) VSS-Rx1 OPM software has been developed that uses a modified algorithm (software that designs the LASIK treatment profile) to limit the induction of postoperative spherical aberration. Commercially available software used to calculate the LASIK treatment profile was used in one eye (active comparator \[i.e., control\]) and VSS-Rx1 OPM software was used in the fellow eye (experimental). Subjects were masked to the use of either the commercially available or VSS-Rx1 OPM software.
Interventions
DEVICEVSS-Rx1 OPM vs Commercial iDesign Treatment
Commercially available iDesign treatment planning software used to calculate the LASIK treatment profile vs VSS-Rx1 OPM (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration).
Sponsors
Abbott Medical Optics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female at least 18 years of age at the time of preoperative exam * Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better * Demonstration of refractive stability * Anticipated postoperative stromal bed thickness of at least 250 microns * Willing and able to return for all study examinations
Exclusion criteria
* 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 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 postoperative course
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Postoperative Spherical Aberration | 3 months | Primary Efficacy Outcome Measure: mean spherical aberration of eyes treated with the VSS-Rx1 OPM treatment planning software compared to that of eyes treated with the commercial iDesign treatment planning software. |
| Percentage of Eyes Losing More Than 2 Lines of Best-corrected Distance Visual Acuity | 3 Months | Primary Safety Outcome Measure: percentage of eyes losing more than 2 lines of best-corrected distance visual acuity |
Countries
Colombia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VSS-Rx1 OPM vs Commercial iDesign Treatment Commercially available software used to calculate the LASIK treatment profile in one eye (active comparator \[i.e., control\]) and investigational software (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration) in the fellow eye (experimental). | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | VSS-Rx1 OPM vs Commercial iDesign Treatment |
|---|---|
| Age, Continuous | 29 years STANDARD_DEVIATION 6.6 |
| Region of Enrollment Colombia | 26 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
Mean Postoperative Spherical Aberration
Primary Efficacy Outcome Measure: mean spherical aberration of eyes treated with the VSS-Rx1 OPM treatment planning software compared to that of eyes treated with the commercial iDesign treatment planning software.
Time frame: 3 months
Population: The analysis population was all evaluable eyes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Commercial iDesign Treatment Planning Software | Mean Postoperative Spherical Aberration | 0.069 µm | Standard Deviation 0.092 |
| VSS-Rx1 OPM Treatment Planning Software | Mean Postoperative Spherical Aberration | 0.016 µm | Standard Deviation 0.108 |
Primary
Percentage of Eyes Losing More Than 2 Lines of Best-corrected Distance Visual Acuity
Primary Safety Outcome Measure: percentage of eyes losing more than 2 lines of best-corrected distance visual acuity
Time frame: 3 Months
Population: The analysis population was all evaluable eyes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Commercial iDesign Treatment Planning Software | Percentage of Eyes Losing More Than 2 Lines of Best-corrected Distance Visual Acuity | 0 percentage of eyes |
| VSS-Rx1 OPM Treatment Planning Software | Percentage of Eyes Losing More Than 2 Lines of Best-corrected Distance Visual Acuity | 0 percentage of eyes |