Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01348854 | Safety and Effectiveness of Arcuate Incisions Performed With the iFS Femtosecond Laser System | PHASE2 | COMPLETED | 40 | — | — | May 1, 2011 | Apr 1, 2013 | Jun 4, 2014 | 4 | Austria, France +1 |
Reduction of astigmatism as determined by manifest refractive cylinder
| Arm | Type | Description |
|---|---|---|
| Natural Astigmatism | EXPERIMENTAL | Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts. |
| Post Cataract with Residual Astigmatism | EXPERIMENTAL | Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted. |
| Name | Type | Description |
|---|---|---|
| iFS Femtosecond Laser System | DEVICE | arcuate incisions placed with the iFS femtosecond laser |
Inclusion Criteria: 1. Male or female, of any race, and at least 21 years of age at the time of pre-op exam 2. Corneal astigmatism, as determined by topographic keratometry, of 0.75 D to 4.00 diopters (D) 3. Best Spectacle Corrected Distance Visual Acuity (BSCVA) 1. Group 1: * Natural as...