An interventional study of Wavelight® Refractive Suite and LASIK surgery in Refractive Error, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-03.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment
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).
427 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.
This study's enrollment of 104 is above the median of 81 across 307 interventional studies indexed under Refractive Errors.
Browse Refractive Errors studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 100 (90%) have results posted.
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Exclusion Criteria:
LASIK surgery (laser in situ keratomileusis) per standard of care
Device: Wavelight® Refractive Suite · Procedure: LASIK surgery
Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation
Surgical procedure for treating refractive error based on corneal reshaping
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.
Time frame: Month 1
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
Participants were recruited from 2 study centers located in the US, 1 study center located in Ireland, and 1 study center located in Germany.
| Milestone | WaveLight Refractive Suite |
|---|---|
| Started | 97 |
| Completed | 96 |
| Not completed | 1 |
| Withdrew: Relocated out of state | 1 |
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.
| logMAR | WaveLight Refractive Suite |
|---|---|
| Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA | -0.0519 ± 0.0075 |
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.
| microns | Operation/Surgery (Day 1) | Month 1 Postoperative | Month 6 Postoperative |
|---|---|---|---|
| Right Eye | 3.958 ± 11.0173 | 3.448 ± 7.6679 | 3.200 ± 7.0795 |
| Left Eye | 3.905 ± 12.2162 | 3.427 ± 7.5096 | 2.253 ± 5.8854 |
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.
| diopter | Baseline/Screening (Day 0) | Day 1 Postoperative | Month 1 Postoperative | Month 3 Postoperative | Month 6 Postoperative |
|---|---|---|---|---|---|
| Mean Manifest Refraction (Sphere) | -3.672 ± 1.9820 | 0.046 ± 0.3318 | 0.077 ± 0.3474 | 0.046 ± 0.3426 | 0.017 ± 0.3383 |
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.
| diopter | Baseline/Screening (Day 0) | Month 1 Postoperative | Month 3 Postoperative | Month 6 Postoperative |
|---|---|---|---|---|
| Mean Manifest Refraction (Cylinder) | -0.32 ± 0.860 | -0.16 ± 0.254 | -0.16 ± 0.217 | -0.18 ± 0.244 |
Treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds.
| seconds | EX500 Laser | FS200 Laser |
|---|---|---|
| Right eye (OD) | 9.912 ± 3.5755 | 30.161 ± 19.1352 |
| Left eye (OS) | 9.709 ± 3.4498 | 29.214 ± 16.4972 |
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.
| seconds | WaveLight Refractive Suite |
|---|---|
| Right eye (OD) | 40.073 ± 19.1612 |
| Left eye (OS) | 38.923 ± 16.6188 |
| Both eyes | 78.996 ± 32.6967 |
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).
| units on a scale | Baseline (Day 0) | Month 1 Postoperative | Month 6 Postoperative |
|---|---|---|---|
| Mean Response: "Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses" | 3.6 ± 1.71 | 9.1 ± 1.08 | 9.4 ± 0.78 |
As recorded by the subject on the RSVP questionnaire, where n/a means no use of glasses or contact lenses.
| percentage of subjects | Baseline (Day 0) | Month 1 Postoperative | Month 6 Postoperative |
|---|---|---|---|
| only glasses | 36.5 | 1.0 | 0.0 |
| mostly glasses, sometimes contact lenses | 32.3 | 0.0 | 0.0 |
| about equally, glasses and contact lenses | 17.7 | 0.0 | 0.0 |
| mostly contact lenses, sometimes glasses | 11.5 | 0.0 | 0.0 |
| only contact lenses | 1.0 | 0.0 | 0.0 |
| n/a | 1.0 | 99.0 | 100.0 |
As recorded by the subject on the RSVP questionnaire
| percentage of subjects | Baseline (Day 0) | Month 1 Postoperative | Month 6 Postoperative |
|---|---|---|---|
| Never | 10.4 | 21.9 | 52.6 |
| Rarely | 30.2 | 51.0 | 33.7 |
| Sometimes | 40.6 | 19.8 | 11.6 |
| Often | 13.5 | 7.3 | 2.1 |
| Always | 5.2 | 0.0 | 0.0 |
As recorded by the subject on the RSVP questionnaire
| percentage of subjects | Baseline (Day 0) | Month 1 Postoperative | Month 6 Postoperative |
|---|---|---|---|
| Never | 6.3 | 27.1 | 63.2 |
| Rarely | 34.4 | 51.0 | 27.4 |
| Sometimes | 34.4 | 14.6 | 5.3 |
| Often | 14.6 | 5.2 | 3.2 |
| Always | 10.4 | 2.1 | 1.1 |
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".
| percentage of subjects | Baseline (Day 0) | Month 1 Postoperative | Month 6 Postoperative |
|---|---|---|---|
| With glasses, 0 | 4.2 | 100.0 | 100.0 |
| With glasses, 1 | 38.5 | 0.0 | 0.0 |
| With glasses, 2 | 34.4 | 0.0 | 0.0 |
| With glasses, 3 | 18.8 | 0.0 | 0.0 |
| With glasses, 4 | 4.2 | 0.0 | 0.0 |
| With glasses, 5 | 0.0 | 0.0 | 0.0 |
| With contact lenses, 0 | 38.5 | 100.0 | 100.0 |
| With contact lenses, 1 | 36.5 | 0.0 | 0.0 |
| With contact lenses, 2 | 20.8 | 0.0 | 0.0 |
| With contact lenses, 3 | 4.2 | 0.0 | 0.0 |
| With contact lenses, 4 | 0.0 | 0.0 | 0.0 |
| With contact lenses, 5 | 0.0 | 0.0 | 0.0 |
| Without glasses/contact lenses, 0 | 29.2 | 3.1 | 0.0 |
| Without glasses/contact lenses, 1 | 0.0 | 43.8 | 73.7 |
| Without glasses/contact lenses, 2 | 0.0 | 40.6 | 21.1 |
| Without glasses/contact lenses, 3 | 4.2 | 8.3 | 4.2 |
| Without glasses/contact lenses, 4 | 8.3 | 3.1 | 1.1 |
| Without glasses/contact lenses, 5 | 58.3 | 1.0 | 0.0 |
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.
| logCS | Baseline (Day 0) | Day 1 Postoperative | Month 1 Postoperative | Month 3 Postoperative | Month 6 Postoperative |
|---|---|---|---|---|---|
| CS A (uncorrected), n=84, 84, 90, 96, 95 | 0.768 ± 0.4356 | 1.845 ± 0.1340 | 1.868 ± 0.1433 | 1.894 ± 0.1168 | 1.898 ± 0.1311 |
| CS B (uncorrected), n=84, 84, 90, 96, 95 | 0.937 ± 0.3991 | 2.035 ± 0.1650 | 2.096 ± 0.1341 | 2.134 ± 0.1267 | 2.117 ± 0.1354 |
| CS C (uncorrected), n=84, 84, 90, 96, 95 | 0.623 ± 0.3995 | 1.734 ± 0.2065 | 1.806 ± 0.1734 | 1.835 ± 0.1640 | 1.854 ± 0.1485 |
| CS D (uncorrected), n=84, 84, 90, 96, 95 | 0.189 ± 0.4188 | 1.273 ± 0.2059 | 1.378 ± 0.1773 | 1.401 ± 0.1517 | 1.411 ± 0.1380 |
| CS A (corrected) | 1.808 ± 0.1399 | 1.863 ± 0.1485 | 1.900 ± 0.1300 | 1.922 ± 0.1242 | 1.917 ± 0.1327 |
| CS B (corrected) | 2.020 ± 0.1880 | 2.056 ± 0.1631 | 2.116 ± 0.1352 | 2.151 ± 0.1217 | 2.148 ± 0.1265 |
| CS C (corrected) | 1.739 ± 0.2095 | 1.757 ± 0.1925 | 1.828 ± 0.1517 | 1.857 ± 0.1391 | 1.876 ± 0.1441 |
| CS D (corrected) | 1.281 ± 0.2014 | 1.311 ± 0.2025 | 1.402 ± 0.1577 | 1.427 ± 0.1346 | 1.432 ± 0.1299 |
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.
| microns | Baseline (Day 0) | Month 6 Postoperative |
|---|---|---|
| Total Higher Order RMS, Right Eye | 0.7 ± 0.97 | 0.5 ± 0.42 |
| Total Higher Order RMS, Left Eye | 0.7 ± 1.12 | 0.5 ± 0.42 |
| Spherical Aberrations, Right Eye | 0.1 ± 0.27 | 0.2 ± 0.13 |
| Spherical Aberrations, Left Eye | 0.1 ± 0.19 | 0.2 ± 0.17 |
| Coma, Right Eye | 0.3 ± 0.42 | 0.3 ± 0.27 |
| Coma, Left Eye | 0.3 ± 0.43 | 0.3 ± 0.19 |
| Trifoil, Right Eye | 0.3 ± 1.02 | 0.4 ± 0.61 |
| Trifoil, Left Eye | 0.3 ± 0.79 | 0.3 ± 0.57 |
Corneal curvature was assessed by a commercially available system and measured in diopters.
| diopter | Baseline (Day 0) | Month 1 Postoperative | Month 3 Postoperative | Month 6 Postoperative |
|---|---|---|---|---|
| K1, Right Eye | 43.5 ± 1.41 | 40.4 ± 1.79 | 40.6 ± 1.76 | 40.6 ± 1.76 |
| K1, Left Eye | 43.5 ± 1.46 | 40.4 ± 1.89 | 40.5 ± 1.88 | 40.5 ± 1.83 |
| K2, Right Eye | 43.9 ± 1.55 | 40.8 ± 1.91 | 41.0 ± 1.91 | 41.0 ± 1.87 |
| K2, Left Eye | 44.0 ± 1.57 | 40.8 ± 1.97 | 40.9 ± 1.96 | 41.0 ± 1.93 |
| Mean K1 and K2, Right Eye | 43.7 ± 1.38 | 40.6 ± 1.81 | 40.8 ± 1.79 | 40.8 ± 1.77 |
| Mean K1 and K2, Left Eye | 43.8 ± 1.42 | 40.6 ± 1.90 | 40.7 ± 1.89 | 40.7 ± 1.84 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| WaveLight Refractive Suite | — | 1/97 (1%) | 0/97 (0%) |
| Screen Failure | — | 0/7 (0%) | 0/7 (0%) |
| Event | WaveLight Refractive Suite | Screen Failure |
|---|---|---|
| Cerebrovascular accidentNervous system disorders | 1/97 | 0/7 |
This analysis population includes all enrolled participants.
| Age, Continuous(years) | WaveLight Refractive Suite |
|---|---|
| Mean | 31.0 ± 6.9 |
| Sex: Female, Male(Participants) | WaveLight Refractive Suite |
|---|---|
| Female | 55 |
| Male | 49 |
No study locations are listed for this record.
The record gives a start of Sep 2013, a primary completion of Jan 2014 and a completion of Aug 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2015, 1 year 2 months after primary completion.
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