Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FS200 femtosecond laser LASIK | Experimental | LASIK flap created with an FS200 femtosecond laser system |
|
| IntraLase femtosecond laser LASIK | Experimental | LASIK flap created with an IntraLase femtosecond laser system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FS200 femtosecond laser LASIK | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of LASIK Flap Thickness | Central LASIK flap thickness for each femtosecond laser. Each treatment was set for a 110 micrometer thick flap. | 3 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| William J Dupps, MD, PhD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24792107 | Result | Rocha KM, Krueger RR. Spectral-domain optical coherence tomography epithelial and flap thickness mapping in femtosecond laser-assisted in situ keratomileusis. Am J Ophthalmol. 2014 Aug;158(2):293-301.e1. doi: 10.1016/j.ajo.2014.04.012. Epub 2014 Apr 30. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Comparison of Femtosecond Lasers in LASIK | Outcomes of femtosecond-assisted LASIK will be compared between yes in subjects using the FS200 femtosecond laser in one eye and the IntraLase in the other. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluation of LASIK Flap Thickness | Central LASIK flap thickness for each femtosecond laser. Each treatment was set for a 110 micrometer thick flap. | Contralateral eyes | Posted | Mean | Standard Deviation | micrometers | 3 months | eyes | eyes |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FS200 Femtosecond Laser LASIK | FS200 femtosecond laser used to create LASIK flap |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William J Dupps, Jr, MD, PhD | Cleveland Clinic | 216-444-8396 |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Contralateral eye study
Not provided
Not provided
Not provided
Not provided
| IntraLase femtosecond laser LASIK |
| Device |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| eyes |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | IntraLase Femotsecond Laser LASIK | IntraLase femtosecond laser used to create LASIK flap | 0 | 33 | 0 | 33 | 0 | 33 |
Not provided
Not provided