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The purpose of this study is to evaluate the thickness accuracy of Laser-assisted in situ keratomileusis (LASIK) flaps created with the LenSx® Laser.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LenSx | Experimental | LASIK surgery in both eyes using LenSx® Femtosecond Laser System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femtosecond Laser System | Device | Used for the creation of a corneal flap in patients undergoing LASIK surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative | Flap thickness was assessed by optical coherence tomography (OCT) and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis. | Month 3 postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative | Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Manager, GCRA | Alcon, A Novartis Division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
Of the 34 enrolled, 4 participants were exited as screen failures prior to surgery. This reporting group includes all treated participants (30).
Participants were recruited from 2 sites located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | LenSx | LASIK surgery in both eyes using LenSx® Femtosecond Laser System |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This analysis population includes all participants/eyes exposed to the device during the study (Safety Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | LenSx | LASIK surgery in both eyes using LenSx® Femtosecond Laser System |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative | Flap thickness was assessed by optical coherence tomography (OCT) and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis. | This analysis population includes the number of eyes treated with surgery and data available. | Posted | Mean | Standard Deviation | micrometers | Month 3 postoperative | Eyes | Eyes |
|
Adverse events (AEs) were collected from time of consent for the duration of participation in the study (up to 5 months). AEs are reported as pre-treatment and treatment-emergent. "At Risk" population for ocular AEs is included with unit of "eyes."
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device.
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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 | Pre-treatment | All who consented to participate in the study prior to the initiation of study treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal striae | Eye disorders | MedDRA (17.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Punctate keratitis | Eye disorders | MedDRA (17.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Brand Med Affairs Lead, CDMA Surgical | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| LASIK surgery | Procedure |
|
| Month 1 postoperative |
| Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative | Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness precision (variability of the achieved flap thickness) was defined as the standard deviation of the flap thickness measurement. Each eye contributed separately to the analysis. | Month 1, Month 3 postoperative |
| Ease of Flap Dissection at Day 0, Operative Day | Ease of flap dissection (ease of lifting the flap during surgery) was assessed on a scale from 0 to 5 where 0 = Unable to lift flap and 5 = Able to lift flap without any resistance using blunt instrument. Each eye contributed separately to the analysis. | Day 0, operative day |
| Stromal Bed Quality at Day 0, Operative Day | Stromal bed quality was assessed by the investigator on a roughness scale from 0 to 5 where 0 = Very rough surface and 5 = Very smooth surface. Each eye contributed separately to the analysis. | Day 0, operative day |
| Opaque Bubble Layer (OBL) at Day 0, Operative Day | Opaque bubble layer was assessed by the investigator during the surgery on a scale from 0 to 5 where 0 = No OBL and 5 = 100% OBL in the stromal bed area. Each eye contributed separately to the analysis. | Day 0, operative day |
| Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative | UCDVA (measurement of uncorrected (without spectacles or other visual corrective devices) distance visual acuity) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed. | Month 1, Month 3 postoperative |
| Best Corrected Distance Visual Acuity (BCDVA) by Visit | BCDVA (measurement with the participant's best spectacle correction) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed. | Baseline, Month 1, Month 3 postoperative |
| Manifest Refraction Spherical Equivalent (MRSE) | The participant was manually refracted to his/her best correction using a phoropter and standard Snellen eye charts. Each eye contributed separately to the analysis. | Baseline, Month 1, Month 3 postoperative |
| Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op | Prediction error was summarized as a percentage of eyes within 0.5 D and 1.0 D of target at one and three months postoperative | Month 1, Month 3 postoperative |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Eyes |
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| Secondary | Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative | Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis. | This analysis population includes the number of eyes treated with surgery and data available. | Posted | Mean | Standard Deviation | micrometers | Month 1 postoperative | Eyes | Eyes |
|
|
|
| Secondary | Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative | Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness precision (variability of the achieved flap thickness) was defined as the standard deviation of the flap thickness measurement. Each eye contributed separately to the analysis. | This analysis population includes the number of eyes treated with surgery and data available. | Posted | Mean | Standard Deviation | micrometers | Month 1, Month 3 postoperative | Eyes | Eyes |
|
|
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| Secondary | Ease of Flap Dissection at Day 0, Operative Day | Ease of flap dissection (ease of lifting the flap during surgery) was assessed on a scale from 0 to 5 where 0 = Unable to lift flap and 5 = Able to lift flap without any resistance using blunt instrument. Each eye contributed separately to the analysis. | Safety Analysis Set | Posted | Mean | Standard Deviation | units on a scale | Day 0, operative day | Eyes | Eyes |
|
|
|
| Secondary | Stromal Bed Quality at Day 0, Operative Day | Stromal bed quality was assessed by the investigator on a roughness scale from 0 to 5 where 0 = Very rough surface and 5 = Very smooth surface. Each eye contributed separately to the analysis. | Safety Analysis Set | Posted | Mean | Standard Deviation | units on a scale | Day 0, operative day | Eyes | Eyes |
|
|
|
| Secondary | Opaque Bubble Layer (OBL) at Day 0, Operative Day | Opaque bubble layer was assessed by the investigator during the surgery on a scale from 0 to 5 where 0 = No OBL and 5 = 100% OBL in the stromal bed area. Each eye contributed separately to the analysis. | Safety Analysis Set | Posted | Mean | Standard Deviation | units on a scale | Day 0, operative day | Eyes | Eyes |
|
|
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| Secondary | Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative | UCDVA (measurement of uncorrected (without spectacles or other visual corrective devices) distance visual acuity) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed. | This analysis population includes the number of eyes treated with surgery and data available. | Posted | Number | percentage of eyes | Month 1, Month 3 postoperative | Eyes | Eyes |
|
|
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| Secondary | Best Corrected Distance Visual Acuity (BCDVA) by Visit | BCDVA (measurement with the participant's best spectacle correction) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed. | This analysis population includes total number of eyes in specified category at visit. | Posted | Number | percentage of eyes | Baseline, Month 1, Month 3 postoperative | Eyes | Eyes |
|
|
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| Secondary | Manifest Refraction Spherical Equivalent (MRSE) | The participant was manually refracted to his/her best correction using a phoropter and standard Snellen eye charts. Each eye contributed separately to the analysis. | This analysis population includes number of eyes in specified category. | Posted | Mean | Standard Deviation | diopter | Baseline, Month 1, Month 3 postoperative | Eyes | Eyes |
|
|
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| Secondary | Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op | Prediction error was summarized as a percentage of eyes within 0.5 D and 1.0 D of target at one and three months postoperative | This analysis population includes the number of eyes treated with surgery and data available at the specified time point. | Posted | Number | percentage of eyes | Month 1, Month 3 postoperative | Eyes | Eyes |
|
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| 0 |
| 68 |
| 0 |
| 68 |
| 0 |
| 68 |
| EG001 | LenSx | All subjects treated with LASIK surgery in both eyes using LenSx® Femtosecond Laser System | 0 | 60 | 1 | 60 | 7 | 60 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| 20/25 |
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| 20/30 |
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| 20/40 |
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| >20/40 |
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| Title | Measurements |
|---|---|
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| 20/25 |
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| 20/30 |
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| 20/40 |
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| >20/40 |
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| Month 1 postoperative |
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| Month 3 postoperative |
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