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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VSS-Rx1 OPM vs Commercial iDesign Treatment | Other | Commercially available iDesign treatment planning 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VSS-Rx1 OPM vs Commercial iDesign Treatment | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| 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 | 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gustavo Tamayo, M.D. | Medico Oftalmologo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustavo Tamayo, M.D. | Bogota Laser, Bogota | Colombia |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This was a paired-eye study in which treatment of 26 participants included both eyes (52 eyes total). Use of the commercial versus VSS-Rx1 OPM treatment planning software was randomized by eye. One eye of each subject received the investigational treatment and the fellow eye received the commercial treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The analysis population was all evaluable eyes. | Posted | Mean | Standard Deviation | µm | 3 months | Eyes | Participants |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Commercial iDesign Treatment Planning Software | Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janice Tarrant | Abbott Medical Optics | 408-273-4163 | janice.tarrant@abbott.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
|
|
| 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 | The analysis population was all evaluable eyes. | Posted | Number | percentage of eyes | 3 Months | Eyes | Participants |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | VSS-Rx1 OPM Treatment Planning Software | Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software | 0 | 26 | 0 | 26 |
The sponsor shall have the first right of publication of study data for the first 12 months. The institution or principal investigator may not disclose any of the Sponsor's proprietary information.