N/A
N=97
WaveLight® Refractive Myopic Study
Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT01941498 ↗Enrolled (actual)
97
Serious AEs
1.0%
Results posted
Mar 2015
Primary outcome: Primary: Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA — -0.0519 logMAR
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 Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA |
-0.0519 | — |
| SECONDARY Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT |
3.958; 3.448; 3.200; 3.905; 3.427; 2.253 | — |
| SECONDARY Mean Manifest Refraction (Sphere) |
-3.672; 0.046; 0.077; 0.046; 0.017 | — |
| SECONDARY Mean Manifest Refraction (Cylinder) |
-0.32; -0.16; -0.16; -0.18 | — |
| SECONDARY Mean Laser Treatment Time |
9.912; 30.161; 9.709; 29.214 | — |
| SECONDARY Mean Total Laser Treatment Time |
40.073; 38.923; 78.996 | — |
| SECONDARY Mean Response: "Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses" |
3.6; 9.1; 9.4 | — |
| SECONDARY Percent Response by Category: "In the Past 4 Weeks, to See Far Away, I Wore..." |
36.5; 1.0; 0.0; 32.3; 0.0; 0.0 | — |
| SECONDARY Percent Response by Category: "I Worry About my Vision" |
10.4; 21.9; 52.6; 30.2; 51.0; 33.7 | — |
| SECONDARY Percent Response by Category: "My Vision Is a Concern in My Daily Life" |
6.3; 27.1; 63.2; 34.4; 51.0; 27.4 | — |
| SECONDARY Percent Response by Category: "Driving at Night" |
4.2; 100.0; 100.0; 38.5; 0.0; 0.0 | — |
| SECONDARY Mean Contrast Sensitivity (CS) |
0.768; 1.845; 1.868; 1.894; 1.898; 0.937 | — |
| SECONDARY Wavefront Aberrometry |
0.7; 0.5; 0.7; 0.5; 0.1; 0.2 | — |
| SECONDARY Corneal Curvature as Measured by Keratometry |
43.5; 40.4; 40.6; 40.6; 43.5; 40.4 | — |
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).
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.
- 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.
Data sourced from ClinicalTrials.gov (NCT01941498). 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.