Myopia
Conditions
Keywords
FS200
Brief summary
The objective is to evaluate the resultant thickness of the FS200 created LASIK flap compared to plan at the surgical visit.
Detailed description
This study is a Single site, single-arm, prospective, observational study of the accuracy of the intended flap thickness, after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 1 day post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and flap thickness, and flap diameter.
Interventions
DEVICEWaveLight® FS200 femtosecond laser
Flap creation with the WaveLight® FS200 femtosecond laser
Sponsors
Sengi
Stephen Wexler
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. * Appropriate candidate for uncomplicated bilateral LASIK surgery * Gender: Males and Females. * Age: 18 or older. * Refractive error range - SE refractive errors up to 0 to -6D with maximum cylinder up to 3.00D * Stable refractive error \<0.50D change in preceding year * Contact lens wear discontinued 3 days prior to pre-op exam and the procedure * Pachymetry above 490μm with residual greater than 270μm * Candidates who, as determined by the investigator, can safely undergo LASIK with a 120μm flap * Willing and able to provide written informed consent for participation in the study. * Willing and able to comply with scheduled visits and other study procedures. * Have good general and ocular health, with no pathology that compromises visual acuity (outside of residual refractive error) If any of the following
Exclusion criteria
are applicable to the subject or either eye, the subject should not be enrolled in the study. * Patients with usual relative and absolute contraindications for LASIK surgery (severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes) * Pachymetry below 490μm * Autoimmune or immunodeficiency diseases * Patients with signs of inability to understand consent for study and procedure planned * Patients with history of previous ocular surgery The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial. Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Resultant Thickness of the FS200 Created LASIK Flap Compared to Plan at the Surgical Visit. | 1 day postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Resultant Diameter of the FS200 Created LASIK Flap Compared to Plan | 1 day postoperative | — |
| Pre-operative Pachymetry as Measured by the EX500 Versus the Oculus Pentacam | Day 0 (surgical visit) | Thickness measurements compared between 2 devices: the EX500 and the Oculus Pentacam |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| WaveLight® FS200 Femtosecond Laser Flap creation with the WaveLight® FS200 femtosecond laser
WaveLight® FS200 femtosecond laser: Flap creation with the WaveLight® FS200 femtosecond laser | 58 |
| Total | 58 |
Baseline characteristics
| Characteristic | WaveLight® FS200 Femtosecond Laser | — |
|---|---|---|
| Age, Continuous | 34.4 years STANDARD_DEVIATION 7.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 26 Participants | — |
| Sex: Female, Male Male | 32 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 58 |
| other Total, other adverse events | 0 / 58 |
| serious Total, serious adverse events | 0 / 58 |
Outcome results
Primary
The Resultant Thickness of the FS200 Created LASIK Flap Compared to Plan at the Surgical Visit.
Time frame: 1 day postoperative
Population: 116 Eyes of 58 participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WaveLight® FS200 Femtosecond Laser | The Resultant Thickness of the FS200 Created LASIK Flap Compared to Plan at the Surgical Visit. | 0.64 um | Standard Deviation 9 |
Secondary
Pre-operative Pachymetry as Measured by the EX500 Versus the Oculus Pentacam
Thickness measurements compared between 2 devices: the EX500 and the Oculus Pentacam
Time frame: Day 0 (surgical visit)
Population: 116 Eyes of 58 participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WaveLight® FS200 Femtosecond Laser | Pre-operative Pachymetry as Measured by the EX500 Versus the Oculus Pentacam | 555.2 um | Standard Deviation 30.9 |
| Pentacam | Pre-operative Pachymetry as Measured by the EX500 Versus the Oculus Pentacam | 553.1 um | Standard Deviation 29.4 |
p-value: <0.001t-test, 2 sided
Secondary
The Resultant Diameter of the FS200 Created LASIK Flap Compared to Plan
Time frame: 1 day postoperative
Population: 116 Eyes of 58 participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WaveLight® FS200 Femtosecond Laser | The Resultant Diameter of the FS200 Created LASIK Flap Compared to Plan | 0.02 mm | Standard Deviation 0.05 |