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To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| wave-front guided LASIK | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LASIK | Device | Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA) | < 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 | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Visual Acuity (UCVA) of 20/40 or Better | 85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters | 3 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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| ID | Title | Description |
|---|---|---|
| FG000 | Wave-front Guided LASIK | Vision correction for a mixed astigmatism refraction |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Wave-front Guided LASIK | LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction |
| 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 | Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA) | < 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 | Posted | Count of Units | eyes | 3 Months | eyes | eyes |
|
|
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 | Wave-front Guided LASIK | LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Operations | Abbott Medical Optics | 714-247-8628 | lachelle.arredondo@abbott.com |
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D020731 | Keratomileusis, Laser In Situ |
| ID | Term |
|---|---|
| D048988 | Corneal Surgery, Laser |
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| eyes |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
| eyes |
|
|
| Secondary | Uncorrected Visual Acuity (UCVA) of 20/40 or Better | 85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters | Posted | Count of Units | eyes | 3 Months | eyes | eyes |
|
|
|
| 0 |
| 84 |
| 0 |
| 84 |
| 0 |
| 84 |
The sponsor must review results communications prior to public release and can embargo communications regarding trial results at any time.
| D013514 |
| Surgical Procedures, Operative |
| D000074431 | Keratectomy |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |