Trial Outcomes & Findings for WaveLight® Refractive Myopic Study (NCT NCT01941498)
NCT ID: NCT01941498
Last Updated: 2015-11-03
Results Overview
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.
COMPLETED
NA
104 participants
Month 1
2015-11-03
Participant Flow
Participants were recruited from 2 study centers located in the US, 1 study center located in Ireland, and 1 study center located in Germany.
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).
Participant milestones
| Measure |
WaveLight Refractive Suite
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
|---|---|
|
Overall Study
STARTED
|
97
|
|
Overall Study
COMPLETED
|
96
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
WaveLight Refractive Suite
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
|---|---|
|
Overall Study
Relocated out of state
|
1
|
Baseline Characteristics
WaveLight® Refractive Myopic Study
Baseline characteristics by cohort
| Measure |
WaveLight Refractive Suite
n=104 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
|---|---|
|
Age, Continuous
|
31.0 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 1Population: This analysis population includes all participants with 1 month post-operative measurement of the primary efficacy endpoint.
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.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=96 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Month 1 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|
|
Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA
|
-0.0519 logMAR
Standard Error 0.0075
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 PostoperativePopulation: This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.
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.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=96 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Month 1 Postoperative
n=96 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
n=95 Participants
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|
|
Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT
Right Eye
|
3.958 microns
Standard Deviation 11.0173
|
3.448 microns
Standard Deviation 7.6679
|
3.200 microns
Standard Deviation 7.0795
|
—
|
—
|
|
Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT
Left Eye
|
3.905 microns
Standard Deviation 12.2162
|
3.427 microns
Standard Deviation 7.5096
|
2.253 microns
Standard Deviation 5.8854
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 PostoperativePopulation: This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.
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.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=192 Eyes
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Month 1 Postoperative
n=192 Eyes
WaveLight Refractive Suite
|
Month 6 Postoperative
n=192 Eyes
WaveLight Refractive Suite
|
Month 3 Postoperative
n=192 Eyes
WaveLight Refractive Suite
|
Month 6 Postoperative
n=190 Eyes
WaveLight Refractive Suite
|
|---|---|---|---|---|---|
|
Mean Manifest Refraction (Sphere)
|
-3.672 diopter
Standard Deviation 1.9820
|
0.046 diopter
Standard Deviation 0.3318
|
0.077 diopter
Standard Deviation 0.3474
|
0.046 diopter
Standard Deviation 0.3426
|
0.017 diopter
Standard Deviation 0.3383
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 PostoperativePopulation: This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.
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.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=192 Eyes
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Month 1 Postoperative
n=192 Eyes
WaveLight Refractive Suite
|
Month 6 Postoperative
n=192 Eyes
WaveLight Refractive Suite
|
Month 3 Postoperative
n=190 Eyes
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|
|
Mean Manifest Refraction (Cylinder)
|
-0.32 diopter
Standard Deviation 0.860
|
-0.16 diopter
Standard Deviation 0.254
|
-0.16 diopter
Standard Deviation 0.217
|
-0.18 diopter
Standard Deviation 0.244
|
—
|
SECONDARY outcome
Timeframe: Day 0 (surgery)Population: This analysis group includes all participants with 1 month post-operative measurement of the primary efficacy endpoint.
Treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=96 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Month 1 Postoperative
n=96 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|
|
Mean Laser Treatment Time
Right eye (OD)
|
9.912 seconds
Standard Deviation 3.5755
|
30.161 seconds
Standard Deviation 19.1352
|
—
|
—
|
—
|
|
Mean Laser Treatment Time
Left eye (OS)
|
9.709 seconds
Standard Deviation 3.4498
|
29.214 seconds
Standard Deviation 16.4972
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (surgery)Population: This analysis group includes all participants with 1 month post-operative measurement of the primary efficacy endpoint.
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.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=96 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Month 1 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|
|
Mean Total Laser Treatment Time
Right eye (OD)
|
40.073 seconds
Standard Deviation 19.1612
|
—
|
—
|
—
|
—
|
|
Mean Total Laser Treatment Time
Left eye (OS)
|
38.923 seconds
Standard Deviation 16.6188
|
—
|
—
|
—
|
—
|
|
Mean Total Laser Treatment Time
Both eyes
|
78.996 seconds
Standard Deviation 32.6967
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Month 1 Postoperative, Month 6 PostoperativePopulation: This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.
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).
Outcome measures
| Measure |
WaveLight Refractive Suite
n=80 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Month 1 Postoperative
n=95 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
n=94 Participants
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|
|
Mean Response: "Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses"
|
3.6 units on a scale
Standard Deviation 1.71
|
9.1 units on a scale
Standard Deviation 1.08
|
9.4 units on a scale
Standard Deviation 0.78
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Month 1 Postoperative, Month 6 PostoperativePopulation: This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.
As recorded by the subject on the RSVP questionnaire, where n/a means no use of glasses or contact lenses.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=96 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Month 1 Postoperative
n=96 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
n=95 Participants
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|
|
Percent Response by Category: "In the Past 4 Weeks, to See Far Away, I Wore..."
only glasses
|
36.5 percentage of subjects
|
1.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "In the Past 4 Weeks, to See Far Away, I Wore..."
mostly glasses, sometimes contact lenses
|
32.3 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "In the Past 4 Weeks, to See Far Away, I Wore..."
about equally, glasses and contact lenses
|
17.7 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "In the Past 4 Weeks, to See Far Away, I Wore..."
mostly contact lenses, sometimes glasses
|
11.5 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "In the Past 4 Weeks, to See Far Away, I Wore..."
only contact lenses
|
1.0 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "In the Past 4 Weeks, to See Far Away, I Wore..."
n/a
|
1.0 percentage of subjects
|
99.0 percentage of subjects
|
100.0 percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Month 1 Postoperative, Month 6 PostoperativePopulation: This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.
As recorded by the subject on the RSVP questionnaire
Outcome measures
| Measure |
WaveLight Refractive Suite
n=96 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Month 1 Postoperative
n=96 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
n=95 Participants
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|
|
Percent Response by Category: "I Worry About my Vision"
Never
|
10.4 percentage of subjects
|
21.9 percentage of subjects
|
52.6 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "I Worry About my Vision"
Rarely
|
30.2 percentage of subjects
|
51.0 percentage of subjects
|
33.7 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "I Worry About my Vision"
Sometimes
|
40.6 percentage of subjects
|
19.8 percentage of subjects
|
11.6 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "I Worry About my Vision"
Often
|
13.5 percentage of subjects
|
7.3 percentage of subjects
|
2.1 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "I Worry About my Vision"
Always
|
5.2 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Month 1 Postoperative, Month 6 PostoperativePopulation: This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.
As recorded by the subject on the RSVP questionnaire
Outcome measures
| Measure |
WaveLight Refractive Suite
n=96 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Month 1 Postoperative
n=96 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
n=95 Participants
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|
|
Percent Response by Category: "My Vision Is a Concern in My Daily Life"
Never
|
6.3 percentage of subjects
|
27.1 percentage of subjects
|
63.2 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "My Vision Is a Concern in My Daily Life"
Rarely
|
34.4 percentage of subjects
|
51.0 percentage of subjects
|
27.4 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "My Vision Is a Concern in My Daily Life"
Sometimes
|
34.4 percentage of subjects
|
14.6 percentage of subjects
|
5.3 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "My Vision Is a Concern in My Daily Life"
Often
|
14.6 percentage of subjects
|
5.2 percentage of subjects
|
3.2 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "My Vision Is a Concern in My Daily Life"
Always
|
10.4 percentage of subjects
|
2.1 percentage of subjects
|
1.1 percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Month 1 Postoperative, Month 6 PostoperativePopulation: This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.
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".
Outcome measures
| Measure |
WaveLight Refractive Suite
n=96 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Month 1 Postoperative
n=96 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
n=95 Participants
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|
|
Percent Response by Category: "Driving at Night"
With contact lenses, 5
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
With glasses, 0
|
4.2 percentage of subjects
|
100.0 percentage of subjects
|
100.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
With glasses, 1
|
38.5 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
With glasses, 2
|
34.4 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
With glasses, 3
|
18.8 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
With glasses, 4
|
4.2 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
With glasses, 5
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
With contact lenses, 0
|
38.5 percentage of subjects
|
100.0 percentage of subjects
|
100.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
With contact lenses, 1
|
36.5 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
With contact lenses, 2
|
20.8 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
With contact lenses, 3
|
4.2 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
With contact lenses, 4
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
Without glasses/contact lenses, 0
|
29.2 percentage of subjects
|
3.1 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
Without glasses/contact lenses, 1
|
0.0 percentage of subjects
|
43.8 percentage of subjects
|
73.7 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
Without glasses/contact lenses, 2
|
0.0 percentage of subjects
|
40.6 percentage of subjects
|
21.1 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
Without glasses/contact lenses, 3
|
4.2 percentage of subjects
|
8.3 percentage of subjects
|
4.2 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
Without glasses/contact lenses, 4
|
8.3 percentage of subjects
|
3.1 percentage of subjects
|
1.1 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
Without glasses/contact lenses, 5
|
58.3 percentage of subjects
|
1.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 PostoperativePopulation: 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.
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.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=96 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Month 1 Postoperative
n=96 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
n=96 Participants
WaveLight Refractive Suite
|
Month 3 Postoperative
n=96 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
n=95 Participants
WaveLight Refractive Suite
|
|---|---|---|---|---|---|
|
Mean Contrast Sensitivity (CS)
CS A (uncorrected), n=84, 84, 90, 96, 95
|
0.768 logCS
Standard Deviation 0.4356
|
1.845 logCS
Standard Deviation 0.1340
|
1.868 logCS
Standard Deviation 0.1433
|
1.894 logCS
Standard Deviation 0.1168
|
1.898 logCS
Standard Deviation 0.1311
|
|
Mean Contrast Sensitivity (CS)
CS B (uncorrected), n=84, 84, 90, 96, 95
|
0.937 logCS
Standard Deviation 0.3991
|
2.035 logCS
Standard Deviation 0.1650
|
2.096 logCS
Standard Deviation 0.1341
|
2.134 logCS
Standard Deviation 0.1267
|
2.117 logCS
Standard Deviation 0.1354
|
|
Mean Contrast Sensitivity (CS)
CS C (uncorrected), n=84, 84, 90, 96, 95
|
0.623 logCS
Standard Deviation 0.3995
|
1.734 logCS
Standard Deviation 0.2065
|
1.806 logCS
Standard Deviation 0.1734
|
1.835 logCS
Standard Deviation 0.1640
|
1.854 logCS
Standard Deviation 0.1485
|
|
Mean Contrast Sensitivity (CS)
CS D (uncorrected), n=84, 84, 90, 96, 95
|
0.189 logCS
Standard Deviation 0.4188
|
1.273 logCS
Standard Deviation 0.2059
|
1.378 logCS
Standard Deviation 0.1773
|
1.401 logCS
Standard Deviation 0.1517
|
1.411 logCS
Standard Deviation 0.1380
|
|
Mean Contrast Sensitivity (CS)
CS A (corrected)
|
1.808 logCS
Standard Deviation 0.1399
|
1.863 logCS
Standard Deviation 0.1485
|
1.900 logCS
Standard Deviation 0.1300
|
1.922 logCS
Standard Deviation 0.1242
|
1.917 logCS
Standard Deviation 0.1327
|
|
Mean Contrast Sensitivity (CS)
CS B (corrected)
|
2.020 logCS
Standard Deviation 0.1880
|
2.056 logCS
Standard Deviation 0.1631
|
2.116 logCS
Standard Deviation 0.1352
|
2.151 logCS
Standard Deviation 0.1217
|
2.148 logCS
Standard Deviation 0.1265
|
|
Mean Contrast Sensitivity (CS)
CS C (corrected)
|
1.739 logCS
Standard Deviation 0.2095
|
1.757 logCS
Standard Deviation 0.1925
|
1.828 logCS
Standard Deviation 0.1517
|
1.857 logCS
Standard Deviation 0.1391
|
1.876 logCS
Standard Deviation 0.1441
|
|
Mean Contrast Sensitivity (CS)
CS D (corrected)
|
1.281 logCS
Standard Deviation 0.2014
|
1.311 logCS
Standard Deviation 0.2025
|
1.402 logCS
Standard Deviation 0.1577
|
1.427 logCS
Standard Deviation 0.1346
|
1.432 logCS
Standard Deviation 0.1299
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Month 6 PostoperativePopulation: This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint.
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.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=96 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Month 1 Postoperative
n=95 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|
|
Wavefront Aberrometry
Total Higher Order RMS, Right Eye
|
0.7 microns
Standard Deviation 0.97
|
0.5 microns
Standard Deviation 0.42
|
—
|
—
|
—
|
|
Wavefront Aberrometry
Total Higher Order RMS, Left Eye
|
0.7 microns
Standard Deviation 1.12
|
0.5 microns
Standard Deviation 0.42
|
—
|
—
|
—
|
|
Wavefront Aberrometry
Spherical Aberrations, Right Eye
|
0.1 microns
Standard Deviation 0.27
|
0.2 microns
Standard Deviation 0.13
|
—
|
—
|
—
|
|
Wavefront Aberrometry
Spherical Aberrations, Left Eye
|
0.1 microns
Standard Deviation 0.19
|
0.2 microns
Standard Deviation 0.17
|
—
|
—
|
—
|
|
Wavefront Aberrometry
Coma, Right Eye
|
0.3 microns
Standard Deviation 0.42
|
0.3 microns
Standard Deviation 0.27
|
—
|
—
|
—
|
|
Wavefront Aberrometry
Coma, Left Eye
|
0.3 microns
Standard Deviation 0.43
|
0.3 microns
Standard Deviation 0.19
|
—
|
—
|
—
|
|
Wavefront Aberrometry
Trifoil, Right Eye
|
0.3 microns
Standard Deviation 1.02
|
0.4 microns
Standard Deviation 0.61
|
—
|
—
|
—
|
|
Wavefront Aberrometry
Trifoil, Left Eye
|
0.3 microns
Standard Deviation 0.79
|
0.3 microns
Standard Deviation 0.57
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 PostoperativePopulation: This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.
Corneal curvature was assessed by a commercially available system and measured in diopters.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=96 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Month 1 Postoperative
n=96 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
n=96 Participants
WaveLight Refractive Suite
|
Month 3 Postoperative
n=95 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|
|
Corneal Curvature as Measured by Keratometry
Mean K1 and K2, Left Eye
|
43.8 diopter
Standard Deviation 1.42
|
40.6 diopter
Standard Deviation 1.90
|
40.7 diopter
Standard Deviation 1.89
|
40.7 diopter
Standard Deviation 1.84
|
—
|
|
Corneal Curvature as Measured by Keratometry
K1, Right Eye
|
43.5 diopter
Standard Deviation 1.41
|
40.4 diopter
Standard Deviation 1.79
|
40.6 diopter
Standard Deviation 1.76
|
40.6 diopter
Standard Deviation 1.76
|
—
|
|
Corneal Curvature as Measured by Keratometry
K1, Left Eye
|
43.5 diopter
Standard Deviation 1.46
|
40.4 diopter
Standard Deviation 1.89
|
40.5 diopter
Standard Deviation 1.88
|
40.5 diopter
Standard Deviation 1.83
|
—
|
|
Corneal Curvature as Measured by Keratometry
K2, Right Eye
|
43.9 diopter
Standard Deviation 1.55
|
40.8 diopter
Standard Deviation 1.91
|
41.0 diopter
Standard Deviation 1.91
|
41.0 diopter
Standard Deviation 1.87
|
—
|
|
Corneal Curvature as Measured by Keratometry
K2, Left Eye
|
44.0 diopter
Standard Deviation 1.57
|
40.8 diopter
Standard Deviation 1.97
|
40.9 diopter
Standard Deviation 1.96
|
41.0 diopter
Standard Deviation 1.93
|
—
|
|
Corneal Curvature as Measured by Keratometry
Mean K1 and K2, Right Eye
|
43.7 diopter
Standard Deviation 1.38
|
40.6 diopter
Standard Deviation 1.81
|
40.8 diopter
Standard Deviation 1.79
|
40.8 diopter
Standard Deviation 1.77
|
—
|
Adverse Events
WaveLight Refractive Suite
Screen Failure
Serious adverse events
| Measure |
WaveLight Refractive Suite
n=97 participants at risk
Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation
|
Screen Failure
n=7 participants at risk
Prior to treatment
|
|---|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
1/97 • 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.
|
0.00%
0/7 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Clinical Project Lead, GCRA, Surgical
Alcon Research, Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER