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The purpose of this study is to evaluate outcomes of subjects undergoing myopic surgery using the WaveLight® Refractive Suite (Excimer EX500 and Femtosecond FS200 lasers).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WaveLight Refractive Suite | Experimental | LASIK surgery (laser in situ keratomileusis) per standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wavelight® Refractive Suite | Device | Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA | Visual acuity (VA) with corrective devices (BCVA) was assessed binocularly (both eyes together) pre-treatment and subtracted from VA without spectacles or other visual corrective devices (UCVA) assessed binocularly at 1 month post-treatment. VA was measured at a distance of 4 meters and reported in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A negative value indicates an improvement in VA from pre-treatment to Month 1. | Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT | The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness as assessed by optical coherence tomography (OCT) (ie, an imaging method using light to capture three-dimensional images). A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Manager, GMA, Surgical | Alcon Research | Study Director |
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Of the 104 enrolled participants, 7 were exited prior to surgery as screen failures. This reporting group includes all enrolled participants who underwent LASIK surgery (97).
Participants were recruited from 2 study centers located in the US, 1 study center located in Ireland, and 1 study center located in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | WaveLight Refractive Suite | Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This analysis population includes all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | WaveLight Refractive Suite | Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation |
| 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 | Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA | Visual acuity (VA) with corrective devices (BCVA) was assessed binocularly (both eyes together) pre-treatment and subtracted from VA without spectacles or other visual corrective devices (UCVA) assessed binocularly at 1 month post-treatment. VA was measured at a distance of 4 meters and reported in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A negative value indicates an improvement in VA from pre-treatment to Month 1. | This analysis population includes all participants with 1 month post-operative measurement of the primary efficacy endpoint. | Posted | Least Squares Mean | Standard Error | logMAR | Month 1 |
|
Adverse events (AEs) were collected for the duration of the study (23 Sep 2013 through 12 Aug 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) 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 | WaveLight Refractive Suite | Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Lead, GCRA, Surgical | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| D006956 | Hyperopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| LASIK surgery | Procedure | Surgical procedure for treating refractive error based on corneal reshaping |
|
| Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative |
| Mean Manifest Refraction (Sphere) | Manifest refraction was performed under photopic lighting conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. Each eye individually contributed to the mean. | Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative |
| Mean Manifest Refraction (Cylinder) | Manifest refraction was performed under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. Each eye individually contributed to the mean. | Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative |
| Mean Laser Treatment Time | Treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds. | Day 0 (surgery) |
| Mean Total Laser Treatment Time | Total treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds. Total duration for both eyes was calculated as sum of duration for the right eye and left eye. | Day 0 (surgery) |
| Mean Response: "Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses" | As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error, on a scale from 0 (completely blind) to 10 (perfect vision). | Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative |
| Percent Response by Category: "In the Past 4 Weeks, to See Far Away, I Wore..." | As recorded by the subject on the RSVP questionnaire, where n/a means no use of glasses or contact lenses. | Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative |
| Percent Response by Category: "I Worry About my Vision" | As recorded by the subject on the RSVP questionnaire | Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative |
| Percent Response by Category: "My Vision Is a Concern in My Daily Life" | As recorded by the subject on the RSVP questionnaire | Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative |
| Percent Response by Category: "Driving at Night" | As recorded by the subject on the RSVP questionnaire, where 0 is "Not applicable", 1 is "No difficulty at all", 2 is "A little difficulty", 3 is "Moderate difficulty", 4 is "Severe difficulty" and 5 is "So much difficulty that I did not do the activity with this alternative". | Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative |
| Mean Contrast Sensitivity (CS) | Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd), where 3.0 cpd = A, 6.0 cpd = B, 12.0 cpd = C, and 18.0 cpd = D. Raw scores were log transformed. A higher numeric value represents better contrast sensitivity. | Baseline (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative |
| Wavefront Aberrometry | Wavefront aberrations (optical imperfections of the eye that prevent light from focusing perfectly on the retina, resulting in defects in the visual image) were measured using a commercially available system. Higher order aberrations (i.e., spherical aberrations, coma, and trifoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology. | Baseline (Day 0), Month 6 Postoperative |
| Corneal Curvature as Measured by Keratometry | Corneal curvature was assessed by a commercially available system and measured in diopters. | Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT | The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness as assessed by optical coherence tomography (OCT) (ie, an imaging method using light to capture three-dimensional images). A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. | This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point. | Posted | Mean | Standard Deviation | microns | Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative |
|
|
|
| Secondary | Mean Manifest Refraction (Sphere) | Manifest refraction was performed under photopic lighting conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. Each eye individually contributed to the mean. | This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point. | Posted | Mean | Standard Deviation | diopter | Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative | Eyes | Participants |
|
|
|
| Secondary | Mean Manifest Refraction (Cylinder) | Manifest refraction was performed under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. Each eye individually contributed to the mean. | This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point. | Posted | Mean | Standard Deviation | diopter | Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative | Eyes | Participants |
|
|
|
| Secondary | Mean Laser Treatment Time | Treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds. | This analysis group includes all participants with 1 month post-operative measurement of the primary efficacy endpoint. | Posted | Mean | Standard Deviation | seconds | Day 0 (surgery) |
|
|
|
| Secondary | Mean Total Laser Treatment Time | Total treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds. Total duration for both eyes was calculated as sum of duration for the right eye and left eye. | This analysis group includes all participants with 1 month post-operative measurement of the primary efficacy endpoint. | Posted | Mean | Standard Deviation | seconds | Day 0 (surgery) |
|
|
|
| Secondary | Mean Response: "Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses" | As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error, on a scale from 0 (completely blind) to 10 (perfect vision). | This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative |
|
|
|
| Secondary | Percent Response by Category: "In the Past 4 Weeks, to See Far Away, I Wore..." | As recorded by the subject on the RSVP questionnaire, where n/a means no use of glasses or contact lenses. | This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point. | Posted | Number | percentage of subjects | Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative |
|
|
|
| Secondary | Percent Response by Category: "I Worry About my Vision" | As recorded by the subject on the RSVP questionnaire | This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point. | Posted | Number | percentage of subjects | Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative |
|
|
|
| Secondary | Percent Response by Category: "My Vision Is a Concern in My Daily Life" | As recorded by the subject on the RSVP questionnaire | This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point. | Posted | Number | percentage of subjects | Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative |
|
|
|
| Secondary | Percent Response by Category: "Driving at Night" | As recorded by the subject on the RSVP questionnaire, where 0 is "Not applicable", 1 is "No difficulty at all", 2 is "A little difficulty", 3 is "Moderate difficulty", 4 is "Severe difficulty" and 5 is "So much difficulty that I did not do the activity with this alternative". | This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point. | Posted | Number | percentage of subjects | Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative |
|
|
|
| Secondary | Mean Contrast Sensitivity (CS) | Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd), where 3.0 cpd = A, 6.0 cpd = B, 12.0 cpd = C, and 18.0 cpd = D. Raw scores were log transformed. A higher numeric value represents better contrast sensitivity. | This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint. Here, "n" is the number of subjects assessed uncorrected. | Posted | Mean | Standard Deviation | logCS | Baseline (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative |
|
|
|
| Secondary | Wavefront Aberrometry | Wavefront aberrations (optical imperfections of the eye that prevent light from focusing perfectly on the retina, resulting in defects in the visual image) were measured using a commercially available system. Higher order aberrations (i.e., spherical aberrations, coma, and trifoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology. | This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint. | Posted | Mean | Standard Deviation | microns | Baseline (Day 0), Month 6 Postoperative |
|
|
|
| Secondary | Corneal Curvature as Measured by Keratometry | Corneal curvature was assessed by a commercially available system and measured in diopters. | This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point. | Posted | Mean | Standard Deviation | diopter | Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative |
|
|
|
| 1 |
| 97 |
| 0 |
| 97 |
| EG001 | Screen Failure | Prior to treatment | 0 | 7 | 0 | 7 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
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| Eyes |
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| Eyes |
|
| Title | Measurements |
|---|---|
|
|
| about equally, glasses and contact lenses |
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| mostly contact lenses, sometimes glasses |
|
| only contact lenses |
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| n/a |
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| Title | Measurements |
|---|---|
|
| Sometimes |
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| Often |
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| Always |
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| Title | Measurements |
|---|---|
|
| Sometimes |
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| Often |
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| Always |
|
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| With glasses, 2 |
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| With glasses, 3 |
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| With glasses, 4 |
|
| With glasses, 5 |
|
| With contact lenses, 0 |
|
| With contact lenses, 1 |
|
| With contact lenses, 2 |
|
| With contact lenses, 3 |
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| With contact lenses, 4 |
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| With contact lenses, 5 |
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| Without glasses/contact lenses, 0 |
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| Without glasses/contact lenses, 1 |
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| Without glasses/contact lenses, 2 |
|
| Without glasses/contact lenses, 3 |
|
| Without glasses/contact lenses, 4 |
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| Without glasses/contact lenses, 5 |
|
| CS B (uncorrected), n=84, 84, 90, 96, 95 |
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| CS C (uncorrected), n=84, 84, 90, 96, 95 |
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| CS D (uncorrected), n=84, 84, 90, 96, 95 |
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| CS A (corrected) |
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| CS B (corrected) |
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| CS C (corrected) |
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| CS D (corrected) |
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| Spherical Aberrations, Right Eye |
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| Spherical Aberrations, Left Eye |
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| Coma, Right Eye |
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| Coma, Left Eye |
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| Trifoil, Right Eye |
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| Trifoil, Left Eye |
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| K1, Left Eye |
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| K2, Right Eye |
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| K2, Left Eye |
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| Mean K1 and K2, Right Eye |
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| Mean K1 and K2, Left Eye |
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