Myopia
Conditions
Brief summary
The objective of this study is to evaluate the visual outcome, accuracy, predictability and complications of LASIK flap creation using the Alcon Wavelight FS200 Femtosecond laser and compare these results to those obtained using current IntraLase FS60 Femtosecond laser. The primary outcome to be evaluated is the flap thickness accuracy.
Detailed description
Laser in situ keratomileusis (LASIK) is a method for treating myopia, hyperopia and astigmatism. In LASIK, the cornea is reshaped to focus images more clearly on the retina without the aid of glasses or contact lenses. LASIK involves two steps: creation of a corneal flap, which can be performed by a mechanical microkeratome or a femtosecond laser, and reshaping of the cornea by another laser, an excimer laser. The accuracy of the LASIK flap thickness is a key safety consideration to reduce the likelihood of complications following LASIK. Femtosecond laser technology has significantly improved the predictability of LASIK flap dimensions while supporting similar visual acuity results. The Alcon FS200 femtosecond laser is approved for human use by the United States Food and Drug Administration and was recently released in the US market. This study will directly compare outcomes of LASIK performed with this newer laser to those performed with the AMO IntraLase femtosecond laser.
Interventions
DEVICEFS200 femtosecond laser LASIK
DEVICEIntraLase femtosecond laser LASIK
Sponsors
Alcon Research
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Contralateral eye study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients with ametropia (Spherical, spherocylindrical, presbyopic) suitable for treatment by LASIK, including different target refractions (Plano or Monovision).
Exclusion criteria
* Patients unsuitable for LASIK procedure because of an estimated residual stromal bed \< 300 microns after calculation of the ablation (Corneal thickness - flap thickness - simulated stromal ablation for the desired correction). * Patients unsuitable for LASIK due suspicious topography for ectasia, form frust keratoconus or unstable ( more than 0.50 diopter change in sphere or cylinder in the last year) refraction. * Patients with amblyopia or any eye disease that might limit the visual recovery. * Patients younger than 18 years old.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of LASIK Flap Thickness | 3 months | Central LASIK flap thickness for each femtosecond laser. Each treatment was set for a 110 micrometer thick flap. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Comparison of Femtosecond Lasers in LASIK Outcomes of femtosecond-assisted LASIK will be compared between yes in subjects using the FS200 laser in one eye and the IntraLase in the other. | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Comparison of Femtosecond Lasers in LASIK |
|---|---|
| Age, Continuous | 30.5 years STANDARD_DEVIATION 4 |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
Primary
Evaluation of LASIK Flap Thickness
Central LASIK flap thickness for each femtosecond laser. Each treatment was set for a 110 micrometer thick flap.
Time frame: 3 months
Population: Contralateral eyes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FS200 Femtosecond Laser LASIK | Evaluation of LASIK Flap Thickness | 105.8 micrometers | Standard Deviation 10.3 |
| IntraLase Femtosecond Laser LASIK | Evaluation of LASIK Flap Thickness | 112.9 micrometers | Standard Deviation 8.2 |
Comparison: Paired Students t-test of FS200 and IntraLase intraoperative flap thickness measurements obtained by ultrasound pachymetryp-value: 0.003t-test, 2 sided