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The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and effective for the correction of myopic refractive errors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| wavefront-guided LASIK | Experimental | LASIK correction of myopic refractive errors. Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LASIK correction of myopic refractive errors | Device | Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kendra Hileman, PhD | Abbott Medical Optics | Study Director |
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334 eyes were treated among 170 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Wavefront-guided LASIK | LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The number of participants is 170, but 334 eyes were evaluated among these 170 participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Wavefront-guided LASIK | LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) | Data from 334 eyes of 170 participants are included for the outcome measure "Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)". | Posted | Number | 95% Confidence Interval | percentage of eyes | 6 Months | eyes | eyes |
|
|
6 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 | Wavefront-guided LASIK | LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Primary open angle glaucoma | Eye disorders | Systematic Assessment | Protocol defines primary open angle glaucoma as a serious adverse event. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ann Murphy, Manager, Clinical Research | Abbott Medical Optics | 619-518-4158 | Ann.Murphy@abbott.org |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| eyes |
|
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| Secondary | Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better | Percentage of eyes with UCVA of 20/40 or better. Target for this outcome measure is greater than 85% achieving UCVA of 20/40 or Better. Data from 334 eyes of 170 participants are included for the outcome measure "Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better". | Posted | Number | 95% Confidence Interval | percentage of eyes | 6 Months | eyes | eyes |
|
|
|
| 5 |
| 334 |
| 0 |
| 334 |
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| Transient light sensitivity syndrome | Eye disorders | Systematic Assessment | Protocol defines transient light sensitivity syndrome as a serious adverse event |
|
| Melting of the flap | Eye disorders | Systematic Assessment | Protocol defines melting of the flap as a serious adverse event |
|
The agreement between the Principal Investigator and the Sponsor (or its agents) restricts the PI's rights to discuss or publish trial results until after the trial is completed and requires prior approval from the sponsor.