Trial Outcomes & Findings for WaveLight® Refractive Flap Accuracy Study (NCT NCT01941485)
NCT ID: NCT01941485
Last Updated: 2017-01-04
Results Overview
The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness at Day 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images). Accuracy of flap creation was defined as an achieved thickness within 10 microns of expected thickness.
COMPLETED
NA
60 participants
Day 1 Postoperative
2017-01-04
Participant Flow
Subjects were recruited from 1 study center located in the US and 1 study center located in Greece.
Of the 60 enrolled subjects, 1 was exited as a screen failure prior to surgery. This reporting group includes all enrolled subjects who underwent LASIK surgery (59).
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
|
59
|
|
Overall Study
COMPLETED
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
WaveLight® Refractive Flap Accuracy Study
Baseline characteristics by cohort
| Measure |
WaveLight Refractive Suite
n=59 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
|---|---|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 9.22 • n=5 Participants
|
|
Gender
Female
|
34 Participants
n=5 Participants
|
|
Gender
Male
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 PostoperativePopulation: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness at Day 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images). Accuracy of flap creation was defined as an achieved thickness within 10 microns of expected thickness.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=59 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
WaveLight Refractive Suite
|
Month 1 Postoperative
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 12 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively
Right eye (OD)
|
14.996 microns
Standard Deviation 12.7509
|
—
|
—
|
—
|
—
|
—
|
|
The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively
Left eye (OS)
|
13.644 microns
Standard Deviation 10.4762
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Operation/Surgery (Day 1)Population: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
OBL (the collection of gas bubbles during corneal flap creation) was assessed by digital photo analysis of the area covered by the flap and is reported as the percentage of participants with opaque bubble layer development during femtosecond flap creation.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=59 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
WaveLight Refractive Suite
|
Month 1 Postoperative
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 12 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Incidence of Development of Opaque Bubble Layer (OBL)
Right eye (OD)
|
20.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Development of Opaque Bubble Layer (OBL)
Left eye (OS)
|
35.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Operation/Surgery (Day 1)Population: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
The extent of OBL was assessed by digital photo analysis of the area covered by the flap and is reported as the percentage of flap with opaque bubble layer development during femtosecond flap creation.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=59 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
WaveLight Refractive Suite
|
Month 1 Postoperative
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 12 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Extent of Opaque Bubble Layer (OBL) Within the Femtosecond Flap
Right eye (OD)
|
8.9 percentage of flap
Standard Deviation 7.59
|
—
|
—
|
—
|
—
|
—
|
|
Extent of Opaque Bubble Layer (OBL) Within the Femtosecond Flap
Left eye (OS)
|
11.1 percentage of flap
Standard Deviation 6.94
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 1 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 subtracted from the achieved flap thickness at Month 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images). Accuracy of flap creation was defined as an achieved thickness within 10 microns of expected thickness.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=58 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
WaveLight Refractive Suite
|
Month 1 Postoperative
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 12 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively
Right eye (OD)
|
8.638 microns
Standard Deviation 5.5177
|
—
|
—
|
—
|
—
|
—
|
|
The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively
Left eye (OS)
|
8.207 microns
Standard Deviation 4.7564
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 PostoperativePopulation: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
Visual acuity (VA) without spectacles or other visual corrective devices, was performed with an Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at a distance of 4 meters. UCVA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=59 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 3 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 12 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Uncorrected Visual Acuity (UCVA)
Right eye (OD)
|
1.078 logMAR
Standard Deviation 0.4042
|
0.043 logMAR
Standard Deviation 0.1469
|
-0.021 logMAR
Standard Deviation 0.1269
|
-0.024 logMAR
Standard Deviation 0.1123
|
-0.041 logMAR
Standard Deviation 0.0982
|
-0.059 logMAR
Standard Deviation 0.1269
|
|
Uncorrected Visual Acuity (UCVA)
Both eyes (OU)
|
1.024 logMAR
Standard Deviation 0.4289
|
-0.011 logMAR
Standard Deviation 0.1118
|
-0.070 logMAR
Standard Deviation 0.0853
|
-0.085 logMAR
Standard Deviation 0.0786
|
-0.084 logMAR
Standard Deviation 0.0858
|
-0.134 logMAR
Standard Deviation 0.0793
|
|
Uncorrected Visual Acuity (UCVA)
Left eye (OS)
|
1.086 logMAR
Standard Deviation 0.3849
|
0.038 logMAR
Standard Deviation 0.1182
|
-0.029 logMAR
Standard Deviation 0.1131
|
-0.027 logMAR
Standard Deviation 0.1129
|
-0.045 logMAR
Standard Deviation 0.1116
|
-0.067 logMAR
Standard Deviation 0.0990
|
SECONDARY outcome
Timeframe: Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 PostoperativePopulation: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
VA with the subjects's best spectacles or other visual corrective devices, was performed with an ETDRS chart set at a distance of 4 meters. BCVA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=59 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 3 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 12 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Best Corrected Visual Acuity (BCVA)
Right eye (OD)
|
-0.046 logMAR
Standard Deviation 0.0855
|
-0.028 logMAR
Standard Deviation 0.1097
|
-0.064 logMAR
Standard Deviation 0.0953
|
-0.072 logMAR
Standard Deviation 0.0877
|
-0.091 logMAR
Standard Deviation 0.0810
|
-0.103 logMAR
Standard Deviation 0.0880
|
|
Best Corrected Visual Acuity (BCVA)
Left eye (OS)
|
-0.042 logMAR
Standard Deviation 0.0894
|
-0.027 logMAR
Standard Deviation 0.0915
|
-0.062 logMAR
Standard Deviation 0.0947
|
-0.070 logMAR
Standard Deviation 0.0967
|
-0.086 logMAR
Standard Deviation 0.0941
|
-0.099 logMAR
Standard Deviation 0.0976
|
|
Best Corrected Visual Acuity (BCVA)
Both eyes (OU)
|
-0.063 logMAR
Standard Deviation 0.0814
|
-0.051 logMAR
Standard Deviation 0.0973
|
-0.096 logMAR
Standard Deviation 0.0907
|
-0.099 logMAR
Standard Deviation 0.0863
|
-0.111 logMAR
Standard Deviation 0.0870
|
-0.148 logMAR
Standard Deviation 0.0837
|
SECONDARY outcome
Timeframe: Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 PostoperativePopulation: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
A series of test lenses in graded powers was used to determine which corrective lenses provided the sharpest, clearest vision. Manifest refraction is measured in diopters. Each eye contributed individually to the analysis.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=118 Eyes
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
WaveLight Refractive Suite
|
Month 1 Postoperative
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 12 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Manifest Refraction (Sphere)
Baseline/Screening (Day 0)
|
-4.254 Diopters
Standard Deviation 2.3340
|
—
|
—
|
—
|
—
|
—
|
|
Manifest Refraction (Sphere)
Day 1 Postoperative
|
-0.347 Diopters
Standard Deviation 0.4174
|
—
|
—
|
—
|
—
|
—
|
|
Manifest Refraction (Sphere)
Month 1 Postoperative
|
-0.186 Diopters
Standard Deviation 0.3304
|
—
|
—
|
—
|
—
|
—
|
|
Manifest Refraction (Sphere)
Month 3 Postoperative
|
-0.153 Diopters
Standard Deviation 0.3049
|
—
|
—
|
—
|
—
|
—
|
|
Manifest Refraction (Sphere)
Month 6 Postoperative
|
-0.167 Diopters
Standard Deviation 0.3253
|
—
|
—
|
—
|
—
|
—
|
|
Manifest Refraction (Sphere)
Month 12 Postoperative
|
-0.165 Diopters
Standard Deviation 0.3190
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 PostoperativePopulation: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
A series of test lenses in graded powers was used to determine which corrective lenses provided the sharpest, clearest vision. Manifest refraction is measured in diopters. Each eye contributed individually to the analysis.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=118 eyes
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
WaveLight Refractive Suite
|
Month 1 Postoperative
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 12 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Manifest Refraction (Cylinder)
Baseline/Screening (Day 0)
|
-0.95 Diopters
Standard Deviation 0.847
|
—
|
—
|
—
|
—
|
—
|
|
Manifest Refraction (Cylinder)
Month 1 Postoperative
|
-0.15 Diopters
Standard Deviation 0.236
|
—
|
—
|
—
|
—
|
—
|
|
Manifest Refraction (Cylinder)
Month 3 Postoperative
|
-0.15 Diopters
Standard Deviation 0.251
|
—
|
—
|
—
|
—
|
—
|
|
Manifest Refraction (Cylinder)
Month 6 Postoperative
|
-0.16 Diopters
Standard Deviation 0.242
|
—
|
—
|
—
|
—
|
—
|
|
Manifest Refraction (Cylinder)
Month 12 Postoperative
|
-0.17 Diopters
Standard Deviation 0.323
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 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.
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. Both eyes contributed to the analysis.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=59 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 3 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 12 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Mean Contrast Sensitivity (CS)
CS A (corrected), n=59, 59, 59, 59, 59
|
1.970 logCS
Standard Deviation 0.1576
|
1.993 logCS
Standard Deviation 0.1310
|
2.003 logCS
Standard Deviation 0.0967
|
2.025 logCS
Standard Deviation 0.1424
|
2.076 logCS
Standard Deviation 0.1126
|
—
|
|
Mean Contrast Sensitivity (CS)
CS B (corrected), n=59, 59, 59, 59, 59
|
2.074 logCS
Standard Deviation 0.1779
|
2.112 logCS
Standard Deviation 0.1502
|
2.100 logCS
Standard Deviation 0.1424
|
2.180 logCS
Standard Deviation 0.1243
|
2.172 logCS
Standard Deviation 0.1545
|
—
|
|
Mean Contrast Sensitivity (CS)
CS A (uncorrected), n=31, 59, 59, 59, 59
|
0.872 logCS
Standard Deviation 0.5604
|
1.996 logCS
Standard Deviation 0.1219
|
1.971 logCS
Standard Deviation 0.1249
|
2.006 logCS
Standard Deviation 0.1585
|
2.046 logCS
Standard Deviation 0.1460
|
—
|
|
Mean Contrast Sensitivity (CS)
CS B (uncorrected), n=30, 59, 59, 59, 59
|
0.986 logCS
Standard Deviation 0.4934
|
2.080 logCS
Standard Deviation 0.1427
|
2.087 logCS
Standard Deviation 0.1571
|
2.148 logCS
Standard Deviation 0.1428
|
2.163 logCS
Standard Deviation 0.1588
|
—
|
|
Mean Contrast Sensitivity (CS)
CS C (uncorrected), n=28, 59, 58, 59, 58
|
0.687 logCS
Standard Deviation 0.4789
|
1.802 logCS
Standard Deviation 0.2096
|
1.802 logCS
Standard Deviation 0.2009
|
1.833 logCS
Standard Deviation 0.2259
|
1.866 logCS
Standard Deviation 0.1727
|
—
|
|
Mean Contrast Sensitivity (CS)
CS D (uncorrected), n=29, 58, 57, 56, 58
|
0.321 logCS
Standard Deviation 0.5745
|
1.317 logCS
Standard Deviation 0.2619
|
1.321 logCS
Standard Deviation 0.2485
|
1.369 logCS
Standard Deviation 0.2517
|
1.396 logCS
Standard Deviation 0.2379
|
—
|
|
Mean Contrast Sensitivity (CS)
CS C (corrected), n=59, 59, 58, 59, 58
|
1.706 logCS
Standard Deviation 0.2716
|
1.815 logCS
Standard Deviation 0.2017
|
1.813 logCS
Standard Deviation 0.1970
|
1.848 logCS
Standard Deviation 0.2211
|
1.897 logCS
Standard Deviation 0.1538
|
—
|
|
Mean Contrast Sensitivity (CS)
CS C (corrected), n=57, 58, 57, 56, 58
|
1.262 logCS
Standard Deviation 0.2657
|
1.338 logCS
Standard Deviation 0.2713
|
1.332 logCS
Standard Deviation 0.2491
|
1.388 logCS
Standard Deviation 0.2501
|
1.422 logCS
Standard Deviation 0.2292
|
—
|
SECONDARY outcome
Timeframe: Operation/Surgery (Day 1), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 PostoperativePopulation: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
The diameter of the corneal flap was assessed by OCT (ie. an imaging method using light to capture three-dimensional images). Corneal flap is measured in millimeters.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=59 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 3 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 12 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT)
Right eye (OD)
|
8.4 millimeters
Standard Deviation 0.25
|
8.4 millimeters
Standard Deviation 0.25
|
8.4 millimeters
Standard Deviation 0.24
|
8.4 millimeters
Standard Deviation 0.25
|
8.4 millimeters
Standard Deviation 0.25
|
8.4 millimeters
Standard Deviation 0.25
|
|
Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT)
Left eye (OS)
|
8.4 millimeters
Standard Deviation 0.27
|
8.4 millimeters
Standard Deviation 0.27
|
8.4 millimeters
Standard Deviation 0.26
|
8.4 millimeters
Standard Deviation 0.27
|
8.4 millimeters
Standard Deviation 0.27
|
8.4 millimeters
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative, Month 12 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.
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 trefoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=59 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
n=57 Participants
WaveLight Refractive Suite
|
Month 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 3 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 12 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Wavefront Aberrometry
Total Higher Order RMS, Right Eye
|
0.37 micrometers
Standard Deviation 0.138
|
0.64 micrometers
Standard Deviation 0.517
|
0.60 micrometers
Standard Deviation 0.445
|
0.65 micrometers
Standard Deviation 0.601
|
—
|
—
|
|
Wavefront Aberrometry
Total Higher Order RMS, Left eye
|
0.40 micrometers
Standard Deviation 0.246
|
0.56 micrometers
Standard Deviation 0.293
|
0.57 micrometers
Standard Deviation 0.318
|
0.58 micrometers
Standard Deviation 0.375
|
—
|
—
|
|
Wavefront Aberrometry
Spherical Aberration, Left Eye
|
0.0851 micrometers
Standard Deviation 0.12651
|
0.1614 micrometers
Standard Deviation 0.20808
|
0.1727 micrometers
Standard Deviation 0.21057
|
0.1954 micrometers
Standard Deviation 0.18350
|
—
|
—
|
|
Wavefront Aberrometry
Coma, Right Eye
|
0.2059 micrometers
Standard Deviation 0.11420
|
0.3656 micrometers
Standard Deviation 0.34574
|
0.3306 micrometers
Standard Deviation 0.34061
|
0.3416 micrometers
Standard Deviation 0.27229
|
—
|
—
|
|
Wavefront Aberrometry
Coma, Left Eye
|
0.2040 micrometers
Standard Deviation 0.16540
|
0.2950 micrometers
Standard Deviation 0.16431
|
0.2927 micrometers
Standard Deviation 0.19461
|
0.2858 micrometers
Standard Deviation 0.18065
|
—
|
—
|
|
Wavefront Aberrometry
Trefoil, Right Eye
|
0.1798 micrometers
Standard Deviation 0.12264
|
0.2316 micrometers
Standard Deviation 0.24752
|
0.2440 micrometers
Standard Deviation 0.22987
|
0.2708 micrometers
Standard Deviation 0.51291
|
—
|
—
|
|
Wavefront Aberrometry
Trefoil, Left Eye
|
0.2192 micrometers
Standard Deviation 0.18534
|
0.2330 micrometers
Standard Deviation 0.21332
|
0.2400 micrometers
Standard Deviation 0.22751
|
0.2403 micrometers
Standard Deviation 0.20733
|
—
|
—
|
|
Wavefront Aberrometry
Spherical Aberration, Right Eye
|
0.0824 micrometers
Standard Deviation 0.13093
|
0.1399 micrometers
Standard Deviation 0.23398
|
0.1646 micrometers
Standard Deviation 0.20307
|
0.1619 micrometers
Standard Deviation 0.19886
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 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=43 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 3 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 12 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Mean Response: "Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses"
|
2.7 units on a scale
Standard Deviation 1.42
|
9.0 units on a scale
Standard Deviation 1.03
|
9.3 units on a scale
Standard Deviation 0.82
|
9.2 units on a scale
Standard Deviation 1.06
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 PostoperativePopulation: This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint.
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.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=59 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 3 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 12 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Percent Response to "Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks"
Yes
|
32.2 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response to "Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks"
No
|
67.8 percentage of subjects
|
100.0 percentage of subjects
|
100.0 percentage of subjects
|
100.0 percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 PostoperativePopulation: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
As recorded by the subject on the RSVP questionnaire
Outcome measures
| Measure |
WaveLight Refractive Suite
n=59 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 3 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 12 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Percent Response by Category: "I Worry About my Vision"
Never
|
15.3 percentage of subjects
|
27.1 percentage of subjects
|
50.8 percentage of subjects
|
55.9 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "I Worry About my Vision"
Rarely
|
33.9 percentage of subjects
|
54.2 percentage of subjects
|
30.5 percentage of subjects
|
23.7 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "I Worry About my Vision"
Sometimes
|
32.2 percentage of subjects
|
8.5 percentage of subjects
|
11.9 percentage of subjects
|
13.6 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "I Worry About my Vision"
Often
|
16.9 percentage of subjects
|
8.5 percentage of subjects
|
5.1 percentage of subjects
|
5.1 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "I Worry About my Vision"
Always
|
1.7 percentage of subjects
|
1.7 percentage of subjects
|
1.7 percentage of subjects
|
1.7 percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 PostoperativePopulation: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
As recorded by the subject on the RSVP questionnaire
Outcome measures
| Measure |
WaveLight Refractive Suite
n=59 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 3 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 12 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Percent Response by Category: "My Vision is a Concern in my Daily Life"
Sometimes
|
33.9 percentage of subjects
|
6.8 percentage of subjects
|
5.1 percentage of subjects
|
6.8 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "My Vision is a Concern in my Daily Life"
Often
|
8.5 percentage of subjects
|
6.8 percentage of subjects
|
3.4 percentage of subjects
|
6.8 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "My Vision is a Concern in my Daily Life"
Always
|
25.4 percentage of subjects
|
10.2 percentage of subjects
|
16.9 percentage of subjects
|
13.6 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "My Vision is a Concern in my Daily Life"
Never
|
3.4 percentage of subjects
|
27.1 percentage of subjects
|
44.1 percentage of subjects
|
50.8 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "My Vision is a Concern in my Daily Life"
Rarely
|
28.8 percentage of subjects
|
49.2 percentage of subjects
|
30.5 percentage of subjects
|
22.0 percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 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=57 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 3 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 12 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Percent Response by Category: "Driving at Night"
With glasses, 5
|
1.8 percentage of subjects
|
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
|
49.1 percentage of subjects
|
100.0 percentage of subjects
|
100.0 percentage of subjects
|
100.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
With contact lenses, 3
|
1.8 percentage of subjects
|
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, 4
|
0.0 percentage of subjects
|
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, 5
|
1.8 percentage of subjects
|
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, 1
|
0.0 percentage of subjects
|
66.1 percentage of subjects
|
76.3 percentage of subjects
|
79.7 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
Without glasses/contact lenses, 2
|
0.0 percentage of subjects
|
18.6 percentage of subjects
|
13.6 percentage of subjects
|
6.8 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
Without glasses/contact lenses, 3
|
1.8 percentage of subjects
|
6.8 percentage of subjects
|
5.1 percentage of subjects
|
3.4 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
With glasses, 0
|
3.5 percentage of subjects
|
100.0 percentage of subjects
|
100.0 percentage of subjects
|
100.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
With glasses, 1
|
42.1 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
With glasses, 2
|
40.4 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
With glasses, 3
|
7.0 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
With glasses, 4
|
5.3 percentage of subjects
|
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, 1
|
35.1 percentage of subjects
|
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, 2
|
12.3 percentage of subjects
|
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
|
33.3 percentage of subjects
|
6.8 percentage of subjects
|
5.1 percentage of subjects
|
5.1 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
Without glasses/contact lenses, 4
|
17.5 percentage of subjects
|
1.7 percentage of subjects
|
0.0 percentage of subjects
|
3.4 percentage of subjects
|
—
|
—
|
|
Percent Response by Category: "Driving at Night"
Without glasses/contact lenses, 5
|
47.4 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
1.7 percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline/Screening (Day 0), 1 Month Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 PostoperativePopulation: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
Corneal curvature as assessed by a commercially available system and measured in diopters.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=59 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 1 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 3 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 6 Postoperative
n=59 Participants
WaveLight Refractive Suite
|
Month 12 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Corneal Curvature as Measured by Keratometry
Mean K1 and K2, Left Eye
|
44.1 diopter
Standard Deviation 1.72
|
40.1 diopter
Standard Deviation 2.42
|
40.2 diopter
Standard Deviation 2.25
|
40.4 diopter
Standard Deviation 2.33
|
40.4 diopter
Standard Deviation 2.30
|
—
|
|
Corneal Curvature as Measured by Keratometry
K1, Right Eye
|
43.4 diopter
Standard Deviation 1.58
|
39.9 diopter
Standard Deviation 2.42
|
39.9 diopter
Standard Deviation 2.43
|
40.0 diopter
Standard Deviation 2.36
|
40.1 diopter
Standard Deviation 2.34
|
—
|
|
Corneal Curvature as Measured by Keratometry
K1, Left Eye
|
43.5 diopter
Standard Deviation 1.74
|
39.8 diopter
Standard Deviation 2.37
|
39.8 diopter
Standard Deviation 2.20
|
39.9 diopter
Standard Deviation 2.31
|
40.0 diopter
Standard Deviation 2.26
|
—
|
|
Corneal Curvature as Measured by Keratometry
K2, Right Eye
|
44.6 diopter
Standard Deviation 1.69
|
40.6 diopter
Standard Deviation 2.59
|
40.7 diopter
Standard Deviation 2.52
|
40.8 diopter
Standard Deviation 2.51
|
40.8 diopter
Standard Deviation 2.47
|
—
|
|
Corneal Curvature as Measured by Keratometry
K2, Left Eye
|
44.7 diopter
Standard Deviation 1.78
|
40.5 diopter
Standard Deviation 2.49
|
40.5 diopter
Standard Deviation 2.32
|
40.8 diopter
Standard Deviation 2.37
|
40.8 diopter
Standard Deviation 2.35
|
—
|
|
Corneal Curvature as Measured by Keratometry
Mean K1 and K2, Right Eye
|
44.0 diopter
Standard Deviation 1.60
|
40.3 diopter
Standard Deviation 2.47
|
40.3 diopter
Standard Deviation 2.46
|
40.4 diopter
Standard Deviation 2.42
|
40.5 diopter
Standard Deviation 2.39
|
—
|
SECONDARY outcome
Timeframe: Operation/Surgery (Day 1)Population: This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.
The time to create the flap with FS200 Femtosecond Flap Creation System, measured in seconds.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=59 Participants
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
WaveLight Refractive Suite
|
Month 1 Postoperative
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 12 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Flap Creation Time as Documented in the Log Files
Right eye (OD)
|
34.864 seconds
Standard Deviation 7.3001
|
—
|
—
|
—
|
—
|
—
|
|
Flap Creation Time as Documented in the Log Files
Left eye (OS)
|
33.220 seconds
Standard Deviation 7.7550
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 PostoperativePopulation: This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, "n" includes all eyes with data.
The Q-value (a measure of corneal asphericity) was assessed using a commercially available system. The Q-values are negative (-1 \< Q \< 0) for prolate corneas, in which the central curvature is steeper than the peripheral curvature, and positive (Q \> 0) for oblate corneas, in which the central curvature is flatter than the peripheral curvature.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=118 Eyes
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
WaveLight Refractive Suite
|
Month 1 Postoperative
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 12 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Corneal Topography: Q-value
Day 1 Postoperative, n=116
|
-0.30 unit less
Standard Deviation 0.661
|
—
|
—
|
—
|
—
|
—
|
|
Corneal Topography: Q-value
Month 1 Postoperative, n=118
|
-0.31 unit less
Standard Deviation 0.652
|
—
|
—
|
—
|
—
|
—
|
|
Corneal Topography: Q-value
Month 3 Postoperative, n=118
|
-0.06 unit less
Standard Deviation 0.769
|
—
|
—
|
—
|
—
|
—
|
|
Corneal Topography: Q-value
Month 6 Postoperative, n=118
|
0.10 unit less
Standard Deviation 0.752
|
—
|
—
|
—
|
—
|
—
|
|
Corneal Topography: Q-value
Month 12 Postoperative, n=118
|
0.02 unit less
Standard Deviation 0.748
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 PostoperativePopulation: This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, "n" includes all eyes with data.
The AC volume (a measure of the shallowness of the anterior chamber) was assessed using a commercially available system. The lower the chamber volume, the more shallow the anterior chamber or the chamber angle.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=118 Eyes
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
WaveLight Refractive Suite
|
Month 1 Postoperative
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 12 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Corneal Topography: Anterior Chamber (AC) Volume
Day 1 Postoperative, n=116
|
189.98 millimeters cubed
Standard Deviation 30.439
|
—
|
—
|
—
|
—
|
—
|
|
Corneal Topography: Anterior Chamber (AC) Volume
Month 1 Postoperative, n=118
|
195.25 millimeters cubed
Standard Deviation 32.134
|
—
|
—
|
—
|
—
|
—
|
|
Corneal Topography: Anterior Chamber (AC) Volume
Month 3 Postoperative, n=118
|
192.91 millimeters cubed
Standard Deviation 31.156
|
—
|
—
|
—
|
—
|
—
|
|
Corneal Topography: Anterior Chamber (AC) Volume
Month 6 Postoperative, n=118
|
191.92 millimeters cubed
Standard Deviation 32.985
|
—
|
—
|
—
|
—
|
—
|
|
Corneal Topography: Anterior Chamber (AC) Volume
Month 12 Postoperative, n=118
|
192.64 millimeters cubed
Standard Deviation 33.382
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 PostoperativePopulation: This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, "n" includes all eyes with data.
The AC depth (axial distance between the anterior surface of the cornea and the anterior surface of the lens) was assessed using a commercially available system. A higher value represents a longer distance.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=118 Eyes
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
WaveLight Refractive Suite
|
Month 1 Postoperative
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 12 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Corneal Topography: Anterior Chamber (AC) Depth
Day 1 Postoperative, n=116
|
3.43 millimeters
Standard Deviation 0.370
|
—
|
—
|
—
|
—
|
—
|
|
Corneal Topography: Anterior Chamber (AC) Depth
Month 1 Postoperative, n=117
|
3.43 millimeters
Standard Deviation 0.349
|
—
|
—
|
—
|
—
|
—
|
|
Corneal Topography: Anterior Chamber (AC) Depth
Month 3 Postoperative, n=118
|
3.38 millimeters
Standard Deviation 0.352
|
—
|
—
|
—
|
—
|
—
|
|
Corneal Topography: Anterior Chamber (AC) Depth
Month 6 Postoperative, n=118
|
3.18 millimeters
Standard Deviation 0.272
|
—
|
—
|
—
|
—
|
—
|
|
Corneal Topography: Anterior Chamber (AC) Depth
Month 12 Postoperative, n=118
|
3.16 millimeters
Standard Deviation 0.276
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 PostoperativePopulation: This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, "n" includes all eyes with data.
The angles (angular measurement of the space between the iris and the lens) were assessed using a commercially available system. The higher the value, the bigger the space.
Outcome measures
| Measure |
WaveLight Refractive Suite
n=118 Eyes
Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
|
Day 1 Postoperative
WaveLight Refractive Suite
|
Month 1 Postoperative
WaveLight Refractive Suite
|
Month 3 Postoperative
WaveLight Refractive Suite
|
Month 6 Postoperative
WaveLight Refractive Suite
|
Month 12 Postoperative
WaveLight Refractive Suite
|
|---|---|---|---|---|---|---|
|
Corneal Topography: Angles
Day 1 Postoperative, n=116
|
41.07 degrees
Standard Deviation 6.612
|
—
|
—
|
—
|
—
|
—
|
|
Corneal Topography: Angles
Month 1 Postoperative, n=118
|
40.63 degrees
Standard Deviation 6.155
|
—
|
—
|
—
|
—
|
—
|
|
Corneal Topography: Angles
Month 3 Postoperative, n=118
|
41.09 degrees
Standard Deviation 6.155
|
—
|
—
|
—
|
—
|
—
|
|
Corneal Topography: Angles
Month 6 Postoperative, n=118
|
40.81 degrees
Standard Deviation 6.141
|
—
|
—
|
—
|
—
|
—
|
|
Corneal Topography: Angles
Month 12 Postoperative, n=118
|
40.74 degrees
Standard Deviation 6.133
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
WaveLight Refractive Suite
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Global Brand Med Affairs Lead, Refractive, VGR
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