WaveLight® Refractive Myopic Study
Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT01941498
Collaborator
(none)
104
1
11
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
104 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Global, Multi-Center Study for the Evaluation of Outcomes on Subjects Undergoing Myopic Treatments Using the WaveLight® Refractive Suite
Study Start Date
:
Sep 1, 2013
Actual Primary Completion Date
:
Jan 1, 2014
Actual Study Completion Date
:
Aug 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: WaveLight Refractive Suite LASIK surgery (laser in situ keratomileusis) per standard of care |
Device: Wavelight® Refractive Suite
Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation
Procedure: LASIK surgery
Surgical procedure for treating refractive error based on corneal reshaping
|
Outcome Measures
Primary Outcome Measures
- Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA [Month 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.
Secondary Outcome Measures
- Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT [Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative]
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.
- Mean Manifest Refraction (Sphere) [Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative]
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.
- Mean Manifest Refraction (Cylinder) [Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative]
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.
- Mean Laser Treatment Time [Day 0 (surgery)]
Treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds.
- Mean Total Laser Treatment Time [Day 0 (surgery)]
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.
- Mean Response: "Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses" [Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative]
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).
- Percent Response by Category: "In the Past 4 Weeks, to See Far Away, I Wore..." [Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative]
As recorded by the subject on the RSVP questionnaire, where n/a means no use of glasses or contact lenses.
- Percent Response by Category: "I Worry About my Vision" [Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative]
As recorded by the subject on the RSVP questionnaire
- Percent Response by Category: "My Vision Is a Concern in My Daily Life" [Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative]
As recorded by the subject on the RSVP questionnaire
- Percent Response by Category: "Driving at Night" [Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative]
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".
- Mean Contrast Sensitivity (CS) [Baseline (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative]
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.
- Wavefront Aberrometry [Baseline (Day 0), Month 6 Postoperative]
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.
- Corneal Curvature as Measured by Keratometry [Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative]
Corneal curvature was assessed by a commercially available system and measured in diopters.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Willing and able to understand and sign an informed consent form.
-
Have refractive error (in both eyes) that requires refractive surgery.
-
Willing to undergo LASIK surgery using the Wavelight® Refractive Suite.
-
Myopia between 0.00 to -12.0 diopters pre-operatively.
-
Astigmatism between 0.00 to +6.00 diopters pre-operatively.
-
Willing and able to attend post-operative examinations per protocol schedule.
-
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
-
Participation in a clinical study within the last 30 days.
-
History of previous corneal surgery in either eye.
-
Multifocal ablations in either eye.
-
PRK or PTK surgery in either eye.
-
Suffering from acute or recurring eye diseases in either eye, such as corneal ulcers, cataract, etc.
-
Any ocular disease and/or condition that, in the Investigator's clinical judgment, may put subject at significant risk, compromise study results, or interfere significantly with subject's participation in the study.
-
Unable to discontinue contact lens wear as specified in protocol.
-
History of Herpes simplex or Herpes zoster keratitis.
-
Active ocular rosacea.
-
Lyme disease.
-
History of dry eye that is unresponsive to treatment.
-
Severe ocular allergies.
-
Other medical conditions and use of medications as specified in protocol.
-
Pregnant or planning to become pregnant during the study.
-
Other protocol-specified exclusion criteria may apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Clinical Manager, GMA, Surgical, Alcon Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT01941498
Other Study ID Numbers:
- A01353
First Posted:
Sep 13, 2013
Last Update Posted:
Nov 3, 2015
Last Verified:
Oct 1, 2015
Keywords provided by Alcon Research
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were recruited from 2 study centers located in the US, 1 study center located in Ireland, and 1 study center located in Germany. |
|---|---|
| Pre-assignment Detail | 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). |
| Arm/Group Title | WaveLight Refractive Suite |
|---|---|
| Arm/Group Description | Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation |
| Period Title: Overall Study | |
| STARTED | 97 |
| COMPLETED | 96 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | WaveLight Refractive Suite |
|---|---|
| Arm/Group Description | Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation |
| Overall Participants | 104 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
31.0
(6.9)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
55
52.9%
|
| Male |
49
47.1%
|
Outcome Measures
| Title | Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all participants with 1 month post-operative measurement of the primary efficacy endpoint. |
| Arm/Group Title | WaveLight Refractive Suite |
|---|---|
| Arm/Group Description | Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation |
| Measure Participants | 96 |
| Least Squares Mean (Standard Error) [logMAR] |
-0.0519
(0.0075)
|
| Title | Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point. |
| Arm/Group Title | Operation/Surgery (Day 1) | Month 1 Postoperative | Month 6 Postoperative |
|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 96 | 96 | 95 |
| 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)
|
| Title | Mean Manifest Refraction (Sphere) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point. |
| Arm/Group Title | Baseline/Screening (Day 0) | Day 1 Postoperative | Month 1 Postoperative | Month 3 Postoperative | Month 6 Postoperative |
|---|---|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 96 | 96 | 96 | 96 | 95 |
| Measure Eyes | 192 | 192 | 192 | 192 | 190 |
| Mean (Standard Deviation) [diopter] |
-3.672
(1.9820)
|
0.046
(0.3318)
|
0.077
(0.3474)
|
0.046
(0.3426)
|
0.017
(0.3383)
|
| Title | Mean Manifest Refraction (Cylinder) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point. |
| Arm/Group Title | Baseline/Screening (Day 0) | Month 1 Postoperative | Month 3 Postoperative | Month 6 Postoperative |
|---|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 96 | 96 | 96 | 95 |
| Measure Eyes | 192 | 192 | 192 | 190 |
| Mean (Standard Deviation) [diopter] |
-0.32
(0.860)
|
-0.16
(0.254)
|
-0.16
(0.217)
|
-0.18
(0.244)
|
| Title | Mean Laser Treatment Time |
|---|---|
| Description | Treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds. |
| Time Frame | Day 0 (surgery) |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis group includes all participants with 1 month post-operative measurement of the primary efficacy endpoint. |
| Arm/Group Title | EX500 Laser | FS200 Laser |
|---|---|---|
| Arm/Group Description | Excimer 500 laser used during LASIK surgery for corneal ablation | Femtosecond FS200 laser used during LASIK surgery for corneal ablation |
| Measure Participants | 96 | 96 |
| Right eye (OD) |
9.912
(3.5755)
|
30.161
(19.1352)
|
| Left eye (OS) |
9.709
(3.4498)
|
29.214
(16.4972)
|
| Title | Mean Total Laser Treatment Time |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis group includes all participants with 1 month post-operative measurement of the primary efficacy endpoint. |
| Arm/Group Title | WaveLight Refractive Suite |
|---|---|
| Arm/Group Description | Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation |
| Measure Participants | 96 |
| Right eye (OD) |
40.073
(19.1612)
|
| Left eye (OS) |
38.923
(16.6188)
|
| Both eyes |
78.996
(32.6967)
|
| Title | Mean Response: "Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses" |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point. |
| Arm/Group Title | Baseline (Day 0) | Month 1 Postoperative | Month 6 Postoperative |
|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 80 | 95 | 94 |
| Mean (Standard Deviation) [units on a scale] |
3.6
(1.71)
|
9.1
(1.08)
|
9.4
(0.78)
|
| Title | Percent Response by Category: "In the Past 4 Weeks, to See Far Away, I Wore..." |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point. |
| Arm/Group Title | Baseline (Day 0) | Month 1 Postoperative | Month 6 Postoperative |
|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 96 | 96 | 95 |
| 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
|
| Title | Percent Response by Category: "I Worry About my Vision" |
|---|---|
| Description | As recorded by the subject on the RSVP questionnaire |
| Time Frame | Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point. |
| Arm/Group Title | Baseline (Day 0) | Month 1 Postoperative | Month 6 Postoperative |
|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 96 | 96 | 95 |
| 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
|
| Title | Percent Response by Category: "My Vision Is a Concern in My Daily Life" |
|---|---|
| Description | As recorded by the subject on the RSVP questionnaire |
| Time Frame | Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point. |
| Arm/Group Title | Baseline (Day 0) | Month 1 Postoperative | Month 6 Postoperative |
|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 96 | 96 | 95 |
| 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
|
| Title | Percent Response by Category: "Driving at Night" |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point. |
| Arm/Group Title | Baseline (Day 0) | Month 1 Postoperative | Month 6 Postoperative |
|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 96 | 96 | 95 |
| 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
|
| Title | Mean Contrast Sensitivity (CS) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Baseline (Day 0) | Day 1 Postoperative | Month 1 Postoperative | Month 3 Postoperative | Month 6 Postoperative |
|---|---|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 96 | 96 | 96 | 96 | 95 |
| 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)
|
| Title | Wavefront Aberrometry |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint. |
| Arm/Group Title | Baseline (Day 0) | Month 6 Postoperative |
|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 96 | 95 |
| 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)
|
| Title | Corneal Curvature as Measured by Keratometry |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point. |
| Arm/Group Title | Baseline (Day 0) | Month 1 Postoperative | Month 3 Postoperative | Month 6 Postoperative |
|---|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 96 | 96 | 96 | 95 |
| 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)
|
Adverse Events
| Time Frame | 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. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||
| Arm/Group Title | WaveLight Refractive Suite | Screen Failure | ||
| Arm/Group Description | Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation | Prior to treatment | ||
All Cause Mortality |
||||
| WaveLight Refractive Suite | Screen Failure | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| WaveLight Refractive Suite | Screen Failure | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/97 (1%) | 0/7 (0%) | ||
| Nervous system disorders | ||||
| Cerebrovascular accident | 1/97 (1%) | 0/7 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| WaveLight Refractive Suite | Screen Failure | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/97 (0%) | 0/7 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
| Name/Title | Clinical Project Lead, GCRA, Surgical |
|---|---|
| Organization | Alcon Research, Ltd. |
| Phone | 1-888-451-3937 |
| alcon.medinfo@alcon.com |
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT01941498
Other Study ID Numbers:
- A01353
First Posted:
Sep 13, 2013
Last Update Posted:
Nov 3, 2015
Last Verified:
Oct 1, 2015