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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01556893 | Creating LASIK Flaps With the LenSx Femtosecond Laser | PHASE1 | COMPLETED | 20 | — | — | Apr 1, 2012 | Mar 1, 2013 | Oct 27, 2014 | 1 | Hungary |
0 - Unable to lift flap 1. \- Able to lift flap with aid of sharp instrument 2. \- Able to lift flap with difficulty using blunt instrument 3. \- Able to lift flap with moderate resistance using blunt instrument 4. \- Able to lift flap with minimal resistance using blunt instrument 5. \- Able to lift flap without any resistance using blunt instrument (Scale)
| Arm | Type | Description |
|---|---|---|
| LASIK Flap Arm | OTHER | This is a single arm study. |
| Name | Type | Description |
|---|---|---|
| LenSx Laser | DEVICE | The LenSx laser system is a femtosecond laser that has received 510(k) clearance for anterior capsulotomy during cataract surgery (K082947), laser phacofragmentation during cataract surgery (K094052) and for use in the creation of a single and multi-plane arc cut/incisions in the cornea (K092647). |
Inclusion Criteria: 1. Must have myopia or hyperopia eligible for femtosecond initiated LASIK surgery 2. Must be over 18 years of age 3. Must have visual acuity correctable to at least 20/25 in both eyes 4. If subject is a contact lens wearer, discontinuation of contact lens wear prior to preoperat...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Cooper Companies, Inc. | COO | 3 | NA | Undisclosed |
| Bausch + Lomb Corporation | BLCO | 4 | NA | Undisclosed |
| Johnson & Johnson | JNJ | 1 | NA | Undisclosed |
| Alcon AG | ALC | 2 | NA | Undisclosed |