Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Demonstrate that wavefront-guided LASIK using measurements from the iDesign System is safe and effective for the treatment of Hyperopia.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| wavefront-guided LASIK | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LASIK correction of hyperopic refractive errors | Device | Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA) | Hypothesis: <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 | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better | Hypothesis: 85% of eyes will have uncorrected visual acuity of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters | 12 Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Surgical Vision Clinical Trials | Johnson & Johnson Surgical Vision | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maloney Vision Institute | Los Angeles | California | 90024 | United States | ||
| University of Miami Bascom Palmer Eye Institute |
No Plan
Not provided
Not provided
Not provided
Not provided
167 subjects were consented in the study, of which 69 subjects had one or both eyes treated for a total of 135 treated eyes.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Wavefront-Guided LASIK | LASIK correction of hyperopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Miami |
| Florida |
| 33136 |
| United States |
| Kraff Eye Institute | Chicago | Illinois | 60602 | United States |
| Pepose Vision Institute | Chesterfield | Missouri | 63017 | United States |
| Durrie Vision | Kansas City | Missouri | 66211 | United States |
| Coleman Vision | Albuquerque | New Mexico | 87109 | United States |
| Lehmann Eye Center | Nacogdoches | Texas | 75965 | United States |
| The Eye Center | Fairfax | Virginia | 22031 | United States |
| King LASIK | Renton | Washington | 98057 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Wavefront-Guided LASIK | LASIK : Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System for correction of hyperopic refractive errors |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA) | Hypothesis: <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 | 12 Months | eyes | eyes |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better | Hypothesis: 85% of eyes will have uncorrected visual acuity of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters | Posted | Count of Units | eyes | 12 Months | eyes | eyes |
|
|
24 months
Not provided
Not provided
| 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 : Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System for correction of hyperopic refractive errors | 0 | 69 | 3 | 69 | 0 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epithelial ingrowth requiring non refractive intervention | Eye disorders | Systematic Assessment |
| ||
| Decrease in BSCVA | Eye disorders | Systematic Assessment |
| ||
| Cataract | Eye disorders | Systematic Assessment |
| ||
| Severe glare | Eye disorders | Systematic Assessment |
|
Not provided
The sponsor must review results communications prior to public release and can embargo communications regarding trial results at any time.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Science | Abbott Medical Optics | 714-247-8613 | khileman@its.jnj.com |
| ID | Term |
|---|---|
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|