WaveLight® Refractive Flap Accuracy Study
Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT01941485
Collaborator
(none)
60
1
16
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the accuracy of the WaveLight FS200 femtosecond laser, as assessed by 1 day and 1 month post-operative optical coherence tomography (OCT) anterior segment corneal measurements compared to pre-operative flap thickness target.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Global, Multi-Center Study to Evaluate Longitudinal Flap Accuracy on Subjects Undergoing Myopic Refractive Surgery Using the WaveLight® Refractive Suite
Study Start Date
:
Oct 1, 2013
Actual Primary Completion Date
:
Jan 1, 2014
Actual Study Completion Date
:
Feb 1, 2015
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
- The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively [Day 1 Postoperative]
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.
Secondary Outcome Measures
- Incidence of Development of Opaque Bubble Layer (OBL) [Operation/Surgery (Day 1)]
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.
- Extent of Opaque Bubble Layer (OBL) Within the Femtosecond Flap [Operation/Surgery (Day 1)]
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.
- The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively [Month 1 Postoperative]
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.
- Uncorrected Visual Acuity (UCVA) [Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative]
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.
- Best Corrected Visual Acuity (BCVA) [Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative]
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.
- Manifest Refraction (Sphere) [Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative]
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.
- Manifest Refraction (Cylinder) [Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative]
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.
- Mean Contrast Sensitivity (CS) [Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 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. Both eyes contributed to the analysis.
- Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT) [Operation/Surgery (Day 1), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative]
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.
- Wavefront Aberrometry [Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative, Month 12 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 trefoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology.
- Mean Response: "Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses" [Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 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 to "Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks" [Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 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.
- Percent Response by Category: "I Worry About my Vision" [Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative]
As recorded by the subject on the RSVP questionnaire
- Percent Response by Category: "My Vision is a Concern in my Daily Life" [Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative]
As recorded by the subject on the RSVP questionnaire
- Percent Response by Category: "Driving at Night" [Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 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".
- Corneal Curvature as Measured by Keratometry [Baseline/Screening (Day 0), 1 Month Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative]
Corneal curvature as assessed by a commercially available system and measured in diopters.
- Flap Creation Time as Documented in the Log Files [Operation/Surgery (Day 1)]
The time to create the flap with FS200 Femtosecond Flap Creation System, measured in seconds.
- Corneal Topography: Q-value [Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative]
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.
- Corneal Topography: Anterior Chamber (AC) Volume [Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative]
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.
- Corneal Topography: Anterior Chamber (AC) Depth [Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative]
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.
- Corneal Topography: Angles [Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative]
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.
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.
-
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: Sr. Clinical Manager, GCRA, Global Med Affairs, Operations, Alcon Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT01941485
Other Study ID Numbers:
- A01354
First Posted:
Sep 13, 2013
Last Update Posted:
Jan 4, 2017
Last Verified:
Nov 1, 2016
Keywords provided by Alcon Research
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subjects were recruited from 1 study center located in the US and 1 study center located in Greece. |
|---|---|
| Pre-assignment Detail | 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). |
| 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 | 59 |
| COMPLETED | 59 |
| NOT COMPLETED | 0 |
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 | 59 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
33.3
(9.22)
|
| Gender (Count of Participants) | |
| Female |
34
57.6%
|
| Male |
25
42.4%
|
Outcome Measures
| Title | The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively |
|---|---|
| Description | 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. |
| Time Frame | Day 1 Postoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness 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 | 59 |
| Right eye (OD) |
14.996
(12.7509)
|
| Left eye (OS) |
13.644
(10.4762)
|
| Title | Incidence of Development of Opaque Bubble Layer (OBL) |
|---|---|
| Description | 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. |
| Time Frame | Operation/Surgery (Day 1) |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness 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 | 59 |
| Right eye (OD) |
20.3
34.4%
|
| Left eye (OS) |
35.6
60.3%
|
| Title | Extent of Opaque Bubble Layer (OBL) Within the Femtosecond Flap |
|---|---|
| Description | 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. |
| Time Frame | Operation/Surgery (Day 1) |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness 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 | 59 |
| Right eye (OD) |
8.9
(7.59)
|
| Left eye (OS) |
11.1
(6.94)
|
| Title | The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively |
|---|---|
| Description | 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. |
| Time Frame | Month 1 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 | 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 | 58 |
| Right eye (OD) |
8.638
(5.5177)
|
| Left eye (OS) |
8.207
(4.7564)
|
| Title | Uncorrected Visual Acuity (UCVA) |
|---|---|
| Description | 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. |
| Time Frame | Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint. |
| Arm/Group Title | Baseline/Screening (Day 0) | Day 1 Postoperative | Month 1 Postoperative | Month 3 Postoperative | Month 6 Postoperative | Month 12 Postoperative |
|---|---|---|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 59 | 59 | 59 | 59 | 59 | 59 |
| Right eye (OD) |
1.078
(0.4042)
|
0.043
(0.1469)
|
-0.021
(0.1269)
|
-0.024
(0.1123)
|
-0.041
(0.0982)
|
-0.059
(0.1269)
|
| Left eye (OS) |
1.086
(0.3849)
|
0.038
(0.1182)
|
-0.029
(0.1131)
|
-0.027
(0.1129)
|
-0.045
(0.1116)
|
-0.067
(0.0990)
|
| Both eyes (OU) |
1.024
(0.4289)
|
-0.011
(0.1118)
|
-0.070
(0.0853)
|
-0.085
(0.0786)
|
-0.084
(0.0858)
|
-0.134
(0.0793)
|
| Title | Best Corrected Visual Acuity (BCVA) |
|---|---|
| Description | 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. |
| Time Frame | Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint. |
| Arm/Group Title | Baseline/Screening (Day 0) | Day 1 Postoperative | Month 1 Postoperative | Month 3 Postoperative | Month 6 Postoperative | Month 12 Postoperative |
|---|---|---|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 59 | 59 | 59 | 59 | 59 | 59 |
| Right eye (OD) |
-0.046
(0.0855)
|
-0.028
(0.1097)
|
-0.064
(0.0953)
|
-0.072
(0.0877)
|
-0.091
(0.0810)
|
-0.103
(0.0880)
|
| Left eye (OS) |
-0.042
(0.0894)
|
-0.027
(0.0915)
|
-0.062
(0.0947)
|
-0.070
(0.0967)
|
-0.086
(0.0941)
|
-0.099
(0.0976)
|
| Both eyes (OU) |
-0.063
(0.0814)
|
-0.051
(0.0973)
|
-0.096
(0.0907)
|
-0.099
(0.0863)
|
-0.111
(0.0870)
|
-0.148
(0.0837)
|
| Title | Manifest Refraction (Sphere) |
|---|---|
| Description | 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. |
| Time Frame | Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness 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 | 59 |
| Measure Eyes | 118 |
| Baseline/Screening (Day 0) |
-4.254
(2.3340)
|
| Day 1 Postoperative |
-0.347
(0.4174)
|
| Month 1 Postoperative |
-0.186
(0.3304)
|
| Month 3 Postoperative |
-0.153
(0.3049)
|
| Month 6 Postoperative |
-0.167
(0.3253)
|
| Month 12 Postoperative |
-0.165
(0.3190)
|
| Title | Manifest Refraction (Cylinder) |
|---|---|
| Description | 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. |
| Time Frame | Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness 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 | 59 |
| Measure eyes | 118 |
| Baseline/Screening (Day 0) |
-0.95
(0.847)
|
| Month 1 Postoperative |
-0.15
(0.236)
|
| Month 3 Postoperative |
-0.15
(0.251)
|
| Month 6 Postoperative |
-0.16
(0.242)
|
| Month 12 Postoperative |
-0.17
(0.323)
|
| 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. Both eyes contributed to the analysis. |
| Time Frame | Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 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 | Month 12 Postoperative |
|---|---|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 59 | 59 | 59 | 59 | 59 |
| CS A (uncorrected), n=31, 59, 59, 59, 59 |
0.872
(0.5604)
|
1.996
(0.1219)
|
1.971
(0.1249)
|
2.006
(0.1585)
|
2.046
(0.1460)
|
| CS B (uncorrected), n=30, 59, 59, 59, 59 |
0.986
(0.4934)
|
2.080
(0.1427)
|
2.087
(0.1571)
|
2.148
(0.1428)
|
2.163
(0.1588)
|
| CS C (uncorrected), n=28, 59, 58, 59, 58 |
0.687
(0.4789)
|
1.802
(0.2096)
|
1.802
(0.2009)
|
1.833
(0.2259)
|
1.866
(0.1727)
|
| CS D (uncorrected), n=29, 58, 57, 56, 58 |
0.321
(0.5745)
|
1.317
(0.2619)
|
1.321
(0.2485)
|
1.369
(0.2517)
|
1.396
(0.2379)
|
| CS A (corrected), n=59, 59, 59, 59, 59 |
1.970
(0.1576)
|
1.993
(0.1310)
|
2.003
(0.0967)
|
2.025
(0.1424)
|
2.076
(0.1126)
|
| CS B (corrected), n=59, 59, 59, 59, 59 |
2.074
(0.1779)
|
2.112
(0.1502)
|
2.100
(0.1424)
|
2.180
(0.1243)
|
2.172
(0.1545)
|
| CS C (corrected), n=59, 59, 58, 59, 58 |
1.706
(0.2716)
|
1.815
(0.2017)
|
1.813
(0.1970)
|
1.848
(0.2211)
|
1.897
(0.1538)
|
| CS C (corrected), n=57, 58, 57, 56, 58 |
1.262
(0.2657)
|
1.338
(0.2713)
|
1.332
(0.2491)
|
1.388
(0.2501)
|
1.422
(0.2292)
|
| Title | Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT) |
|---|---|
| Description | 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. |
| Time Frame | Operation/Surgery (Day 1), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint. |
| Arm/Group Title | Operation/Surgery (Day 1) | Day 1 Postoperative | Month 1 Postoperative | Month 3 Postoperative | Month 6 Postoperative | Month 12 Postoperative |
|---|---|---|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 59 | 59 | 59 | 59 | 59 | 59 |
| Right eye (OD) |
8.4
(0.25)
|
8.4
(0.25)
|
8.4
(0.24)
|
8.4
(0.25)
|
8.4
(0.25)
|
8.4
(0.25)
|
| Left eye (OS) |
8.4
(0.27)
|
8.4
(0.27)
|
8.4
(0.26)
|
8.4
(0.27)
|
8.4
(0.27)
|
8.4
(0.27)
|
| 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 trefoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology. |
| Time Frame | Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative, Month 12 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 | Month 12 Postoperative |
|---|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 59 | 57 | 59 | 59 |
| Total Higher Order RMS, Right Eye |
0.37
(0.138)
|
0.64
(0.517)
|
0.60
(0.445)
|
0.65
(0.601)
|
| Total Higher Order RMS, Left eye |
0.40
(0.246)
|
0.56
(0.293)
|
0.57
(0.318)
|
0.58
(0.375)
|
| Spherical Aberration, Right Eye |
0.0824
(0.13093)
|
0.1399
(0.23398)
|
0.1646
(0.20307)
|
0.1619
(0.19886)
|
| Spherical Aberration, Left Eye |
0.0851
(0.12651)
|
0.1614
(0.20808)
|
0.1727
(0.21057)
|
0.1954
(0.18350)
|
| Coma, Right Eye |
0.2059
(0.11420)
|
0.3656
(0.34574)
|
0.3306
(0.34061)
|
0.3416
(0.27229)
|
| Coma, Left Eye |
0.2040
(0.16540)
|
0.2950
(0.16431)
|
0.2927
(0.19461)
|
0.2858
(0.18065)
|
| Trefoil, Right Eye |
0.1798
(0.12264)
|
0.2316
(0.24752)
|
0.2440
(0.22987)
|
0.2708
(0.51291)
|
| Trefoil, Left Eye |
0.2192
(0.18534)
|
0.2330
(0.21332)
|
0.2400
(0.22751)
|
0.2403
(0.20733)
|
| 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/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 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 6 Postoperative | Month 12 Postoperative |
|---|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 43 | 59 | 59 | 59 |
| Mean (Standard Deviation) [units on a scale] |
2.7
(1.42)
|
9.0
(1.03)
|
9.3
(0.82)
|
9.2
(1.06)
|
| Title | Percent Response to "Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks" |
|---|---|
| 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. |
| Time Frame | Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 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/Screening (Day 0) | Month 1 Postoperative | Month 6 Postoperative | Month 12 Postoperative |
|---|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 59 | 59 | 59 | 59 |
| No |
67.8
|
100.0
|
100.0
|
100.0
|
| Yes |
32.2
|
0.0
|
0.0
|
0.0
|
| Title | Percent Response by Category: "I Worry About my Vision" |
|---|---|
| Description | As recorded by the subject on the RSVP questionnaire |
| Time Frame | Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint. |
| Arm/Group Title | Baseline/Screening (Day 0) | Month 1 Postoperative | Month 6 Postoperative | Month 12 Postoperative |
|---|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 59 | 59 | 59 | 59 |
| Never |
15.3
|
27.1
|
50.8
|
55.9
|
| Rarely |
33.9
|
54.2
|
30.5
|
23.7
|
| Sometimes |
32.2
|
8.5
|
11.9
|
13.6
|
| Often |
16.9
|
8.5
|
5.1
|
5.1
|
| Always |
1.7
|
1.7
|
1.7
|
1.7
|
| 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/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint. |
| Arm/Group Title | Baseline/Screening (Day 0) | Month 1 Postoperative | Month 6 Postoperative | Month 12 Postoperative |
|---|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 59 | 59 | 59 | 59 |
| Never |
3.4
|
27.1
|
44.1
|
50.8
|
| Rarely |
28.8
|
49.2
|
30.5
|
22.0
|
| Sometimes |
33.9
|
6.8
|
5.1
|
6.8
|
| Often |
8.5
|
6.8
|
3.4
|
6.8
|
| Always |
25.4
|
10.2
|
16.9
|
13.6
|
| 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/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 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 6 Postoperative | Month 12 Postoperative |
|---|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 57 | 59 | 59 | 59 |
| With glasses, 0 |
3.5
|
100.0
|
100.0
|
100.0
|
| With glasses, 1 |
42.1
|
0.0
|
0.0
|
0.0
|
| With glasses, 2 |
40.4
|
0.0
|
0.0
|
0.0
|
| With glasses, 3 |
7.0
|
0.0
|
0.0
|
0.0
|
| With glasses, 4 |
5.3
|
0.0
|
0.0
|
0.0
|
| With glasses, 5 |
1.8
|
0.0
|
0.0
|
0.0
|
| With contact lenses, 0 |
49.1
|
100.0
|
100.0
|
100.0
|
| With contact lenses, 1 |
35.1
|
0.0
|
0.0
|
0.0
|
| With contact lenses, 2 |
12.3
|
0.0
|
0.0
|
0.0
|
| With contact lenses, 3 |
1.8
|
0.0
|
0.0
|
0.0
|
| With contact lenses, 4 |
0.0
|
0.0
|
0.0
|
0.0
|
| With contact lenses, 5 |
1.8
|
0.0
|
0.0
|
0.0
|
| Without glasses/contact lenses, 0 |
33.3
|
6.8
|
5.1
|
5.1
|
| Without glasses/contact lenses, 1 |
0.0
|
66.1
|
76.3
|
79.7
|
| Without glasses/contact lenses, 2 |
0.0
|
18.6
|
13.6
|
6.8
|
| Without glasses/contact lenses, 3 |
1.8
|
6.8
|
5.1
|
3.4
|
| Without glasses/contact lenses, 4 |
17.5
|
1.7
|
0.0
|
3.4
|
| Without glasses/contact lenses, 5 |
47.4
|
0.0
|
0.0
|
1.7
|
| Title | Corneal Curvature as Measured by Keratometry |
|---|---|
| Description | Corneal curvature as assessed by a commercially available system and measured in diopters. |
| Time Frame | Baseline/Screening (Day 0), 1 Month Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint. |
| Arm/Group Title | Baseline/Screening (Day 0) | Month 1 Postoperative | Month 3 Postoperative | Month 6 Postoperative | Month 12 Postoperative |
|---|---|---|---|---|---|
| Arm/Group Description | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite | WaveLight Refractive Suite |
| Measure Participants | 59 | 59 | 59 | 59 | 59 |
| K1, Right Eye |
43.4
(1.58)
|
39.9
(2.42)
|
39.9
(2.43)
|
40.0
(2.36)
|
40.1
(2.34)
|
| K1, Left Eye |
43.5
(1.74)
|
39.8
(2.37)
|
39.8
(2.20)
|
39.9
(2.31)
|
40.0
(2.26)
|
| K2, Right Eye |
44.6
(1.69)
|
40.6
(2.59)
|
40.7
(2.52)
|
40.8
(2.51)
|
40.8
(2.47)
|
| K2, Left Eye |
44.7
(1.78)
|
40.5
(2.49)
|
40.5
(2.32)
|
40.8
(2.37)
|
40.8
(2.35)
|
| Mean K1 and K2, Right Eye |
44.0
(1.60)
|
40.3
(2.47)
|
40.3
(2.46)
|
40.4
(2.42)
|
40.5
(2.39)
|
| Mean K1 and K2, Left Eye |
44.1
(1.72)
|
40.1
(2.42)
|
40.2
(2.25)
|
40.4
(2.33)
|
40.4
(2.30)
|
| Title | Flap Creation Time as Documented in the Log Files |
|---|---|
| Description | The time to create the flap with FS200 Femtosecond Flap Creation System, measured in seconds. |
| Time Frame | Operation/Surgery (Day 1) |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint. |
| Arm/Group Title | FS200 Laser |
|---|---|
| Arm/Group Description | Femtosecond FS200 laser used during LASIK surgery for corneal flap creation |
| Measure Participants | 59 |
| Right eye (OD) |
34.864
(7.3001)
|
| Left eye (OS) |
33.220
(7.7550)
|
| Title | Corneal Topography: Q-value |
|---|---|
| Description | 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. |
| Time Frame | Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, "n" includes all eyes with data. |
| Arm/Group Title | Q-Value |
|---|---|
| Arm/Group Description | WaveLight Refractive Suite |
| Measure Participants | 59 |
| Measure Eyes | 118 |
| Day 1 Postoperative, n=116 |
-0.30
(0.661)
|
| Month 1 Postoperative, n=118 |
-0.31
(0.652)
|
| Month 3 Postoperative, n=118 |
-0.06
(0.769)
|
| Month 6 Postoperative, n=118 |
0.10
(0.752)
|
| Month 12 Postoperative, n=118 |
0.02
(0.748)
|
| Title | Corneal Topography: Anterior Chamber (AC) Volume |
|---|---|
| Description | 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. |
| Time Frame | Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, "n" includes all eyes with data. |
| Arm/Group Title | AC Volume |
|---|---|
| Arm/Group Description | WaveLight Refractive Suite |
| Measure Participants | 59 |
| Measure Eyes | 118 |
| Day 1 Postoperative, n=116 |
189.98
(30.439)
|
| Month 1 Postoperative, n=118 |
195.25
(32.134)
|
| Month 3 Postoperative, n=118 |
192.91
(31.156)
|
| Month 6 Postoperative, n=118 |
191.92
(32.985)
|
| Month 12 Postoperative, n=118 |
192.64
(33.382)
|
| Title | Corneal Topography: Anterior Chamber (AC) Depth |
|---|---|
| Description | 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. |
| Time Frame | Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, "n" includes all eyes with data. |
| Arm/Group Title | AC Depth |
|---|---|
| Arm/Group Description | WaveLight Refractive Suite |
| Measure Participants | 59 |
| Measure Eyes | 118 |
| Day 1 Postoperative, n=116 |
3.43
(0.370)
|
| Month 1 Postoperative, n=117 |
3.43
(0.349)
|
| Month 3 Postoperative, n=118 |
3.38
(0.352)
|
| Month 6 Postoperative, n=118 |
3.18
(0.272)
|
| Month 12 Postoperative, n=118 |
3.16
(0.276)
|
| Title | Corneal Topography: Angles |
|---|---|
| Description | 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. |
| Time Frame | Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, "n" includes all eyes with data. |
| Arm/Group Title | Angles |
|---|---|
| Arm/Group Description | WaveLight Refractive Suite |
| Measure Participants | 59 |
| Measure Eyes | 118 |
| Day 1 Postoperative, n=116 |
41.07
(6.612)
|
| Month 1 Postoperative, n=118 |
40.63
(6.155)
|
| Month 3 Postoperative, n=118 |
41.09
(6.155)
|
| Month 6 Postoperative, n=118 |
40.81
(6.141)
|
| Month 12 Postoperative, n=118 |
40.74
(6.133)
|
Adverse Events
| Time Frame | Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 12 months). This reporting group includes all enrolled subjects who underwent LASIK surgery. | |
|---|---|---|
| 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 | |
| Arm/Group Description | Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation | |
All Cause Mortality |
||
| WaveLight Refractive Suite | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| WaveLight Refractive Suite | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/59 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| WaveLight Refractive Suite | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/59 (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 | Global Brand Med Affairs Lead, Refractive, VGR |
|---|---|
| Organization | Alcon Research, Ltd. |
| Phone | 1-888-451-3937 |
| alcon.medinfo@alcon.com |
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT01941485
Other Study ID Numbers:
- A01354
First Posted:
Sep 13, 2013
Last Update Posted:
Jan 4, 2017
Last Verified:
Nov 1, 2016