N/A
N=59
WaveLight® Refractive Flap Accuracy Study
Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT01941485 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively — 14.996; 13.644 microns
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- WaveLight® Refractive Suite (Device); LASIK surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively |
14.996; 13.644 | — |
| SECONDARY Incidence of Development of Opaque Bubble Layer (OBL) |
20.3; 35.6 | — |
| SECONDARY Extent of Opaque Bubble Layer (OBL) Within the Femtosecond Flap |
8.9; 11.1 | — |
| SECONDARY The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively |
8.638; 8.207 | — |
| SECONDARY Uncorrected Visual Acuity (UCVA) |
1.078; 0.043; -0.021; -0.024; -0.041; -0.059 | — |
| SECONDARY Best Corrected Visual Acuity (BCVA) |
-0.046; -0.028; -0.064; -0.072; -0.091; -0.103 | — |
| SECONDARY Manifest Refraction (Sphere) |
-4.254; -0.347; -0.186; -0.153; -0.167; -0.165 | — |
| SECONDARY Manifest Refraction (Cylinder) |
-0.95; -0.15; -0.15; -0.16; -0.17 | — |
| SECONDARY Mean Contrast Sensitivity (CS) |
0.872; 1.996; 1.971; 2.006; 2.046; 0.986 | — |
| SECONDARY Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT) |
8.4; 8.4; 8.4; 8.4; 8.4; 8.4 | — |
| SECONDARY Wavefront Aberrometry |
0.37; 0.64; 0.60; 0.65; 0.40; 0.56 | — |
| SECONDARY Mean Response: "Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses" |
2.7; 9.0; 9.3; 9.2 | — |
| SECONDARY Percent Response to "Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks" |
67.8; 100.0; 100.0; 100.0; 32.2; 0.0 | — |
| SECONDARY Percent Response by Category: "I Worry About my Vision" |
15.3; 27.1; 50.8; 55.9; 33.9; 54.2 | — |
| SECONDARY Percent Response by Category: "My Vision is a Concern in my Daily Life" |
3.4; 27.1; 44.1; 50.8; 28.8; 49.2 | — |
| SECONDARY Percent Response by Category: "Driving at Night" |
3.5; 100.0; 100.0; 100.0; 42.1; 0.0 | — |
| SECONDARY Corneal Curvature as Measured by Keratometry |
43.4; 39.9; 39.9; 40.0; 40.1; 43.5 | — |
| SECONDARY Flap Creation Time as Documented in the Log Files |
34.864; 33.220 | — |
| SECONDARY Corneal Topography: Q-value |
-0.30; -0.31; -0.06; 0.10; 0.02 | — |
| SECONDARY Corneal Topography: Anterior Chamber (AC) Volume |
189.98; 195.25; 192.91; 191.92; 192.64 | — |
| SECONDARY Corneal Topography: Anterior Chamber (AC) Depth |
3.43; 3.43; 3.38; 3.18; 3.16 | — |
| SECONDARY Corneal Topography: Angles |
41.07; 40.63; 41.09; 40.81; 40.74 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01941485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.