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
Not provided
Not provided
The results of this trial will demonstrate that AVSS software performs as intended and is acceptable in a clinical setting.
LASIK treatment across the range of myopia with or without astigmatism, hyperopia with or without astigmatism, and mixed astigmatism.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refractive Error | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STAR S4IR LASIK with VSS-R ablation profile | Device | LASIK treatment targeted for emmetropia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better | 1 Year |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Percent Manifest Refraction Spherical Equivalent Within 1.0D | Manifest refraction spherical equivalent is the required spectacle (or glass) prescription. | 1 Year |
| Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicholas Tarantino, OD | Abbott Medical Optics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Laser Eye Centre | Abbottsford | British Columbia | V2S 3R1 | Canada | ||
| Clearly LASIK |
Not provided
One or both eyes of 79 subjects (150 eyes) were treated.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Myopia With and Without Astigmatism | Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D. |
| FG001 | Hyperopia With and Without Astigmatism | Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D. |
| FG002 | Mixed Astigmatism | Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Myopia With or Without Astigmatism | Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D. |
| BG001 | Hyperopia With and Without Astigmatism |
| 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 | Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better | As a measure of effectiveness of LASIK treatment with VSS, distance visual performance without spectacles, clinically measured as Uncorrected Visual Acuity (UCVA) will be measured under standardized conditions such as 4 meter testing distance, controlled ambient room lighting and standard eye charts. | Posted | Number | 95% Confidence Interval | percentage of eyes | 1 Year | eyes | Participants |
|
1 year
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 | Myopia With or Without Astigmatism | Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decrease in BSCVA of greater than or equal to two lines | Eye disorders | Systematic Assessment | Loss of greater than or equal to two lines of BSCVA is an SAE in the context of this study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inadvertent insallation of Tropicamide instead of Tetracaine | Eye disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amelia Saliba | Abbott Medical Optics | 408-273-4158 | amelia.saliba@amo.abbott.com |
Not provided
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
After surgery, with or without best spectacle prescription the subject is not expected to see worse than before surgery. As a metric for this safety endpoint, losses of 2 lines of vision on a standard eye chart, with best spectacle correction, after surgery compared to pre-operative baseline shall be evaluated. For example 20/20 is typically considered best vision and 2 lines worse than this will be 20/32).
| 1 Year |
| Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power | 1 Year |
| Victoria |
| British Columbia |
| V8X 1X2 |
| Canada |
| Image Plus Laser Eye Center | Winnipeg | Manitoba | R3C 3J5 | Canada |
| University of Ottawa Eye Institute | Ottawa | Ontario | K1H 8LB | Canada |
| Yonge-Eglington Laser | Toronto | Ontario | M4P 2E5 | Canada |
Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
| BG002 | Mixed Astigmatism | Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Mixed Astigmatism | Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs. |
|
|
| Other Pre-specified | Percent Manifest Refraction Spherical Equivalent Within 1.0D | Manifest refraction spherical equivalent is the required spectacle (or glass) prescription. | As a measure of effectiveness of LASIK treatment with VSS, the required spectacle prescription, also called manifest refraction, will be measured under standardized conditions such as 4 meter testing distance, controlled ambient room lighting and standard eye charts. | Posted | Number | 95% Confidence Interval | percentage of eyes | 1 Year | eyes | Participants |
|
|
|
| Other Pre-specified | Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) | After surgery, with or without best spectacle prescription the subject is not expected to see worse than before surgery. As a metric for this safety endpoint, losses of 2 lines of vision on a standard eye chart, with best spectacle correction, after surgery compared to pre-operative baseline shall be evaluated. For example 20/20 is typically considered best vision and 2 lines worse than this will be 20/32). | Posted | Number | 95% Confidence Interval | percentage of eyes | 1 Year | eyes | Participants |
|
|
|
| Other Pre-specified | Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power | Posted | Number | 95% Confidence Interval | percentage of eyes | 1 Year | eyes | Participants |
|
|
|
| 0 |
| 57 |
| 17 |
| 57 |
| EG001 | Hyperopia With and Without Astigmatism | Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D. | 1 | 13 | 12 | 13 |
| EG002 | Mixed Astigmatism | Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs. | 0 | 9 | 0 | 9 |
|
| Elevated IOP (temporary) | Eye disorders | Systematic Assessment |
|
| Photic phenomena (i.e., halos, glare, starbursts) | Eye disorders | Systematic Assessment |
|
| Corneal Haze | Eye disorders | Systematic Assessment |
|
| Dry eye | Eye disorders | Systematic Assessment |
|
| Double vision | Eye disorders | Systematic Assessment |
|
| Superficial epithelial linear laceration | Eye disorders | Systematic Assessment |
|
| Peripheral infiltrates | Eye disorders | Systematic Assessment |
|
| Other - hairline ankle fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Other - cold/flu | General disorders | Systematic Assessment |
|
At least ninety (90) days prior to any proposed submission for publication or presentation of Study Data or other findings related to the Study, Institution will provide Sponsor with a manuscript of such submission(s) for review, comment, and approval. For greater certainty, neither Institution nor Principal Investigator shall have any right to publish any information or results concerning the Study without the express written consent of Sponsor.