Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LenSx Laser · 1 trial · 2 indications
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 | N/A | Undisclosed |
| Bausch + Lomb Corporation | BLCO | 4 | N/A | Undisclosed |
| Johnson & Johnson | JNJ | 1 | N/A | Undisclosed |
| Alcon AG | ALC | 2 | N/A | Undisclosed |
| S-Alpha Therapeutics, Inc. | YCBD | 1 | N/A | Undisclosed |
LenSx Laser is an investigational femtosecond laser system being studied for use in creating LASIK flaps in patients with myopia and hyperopia. It is an ophthalmology device under development by Alcon Inc. for refractive vision correction procedures.
LenSx Laser is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker symbol ALC. Alcon is a global medical device company specializing in eye care products and surgical equipment.
LenSx Laser is in Phase 1 clinical development. It is an investigational device and has not been approved by regulatory authorities. The device is currently being evaluated in early-stage clinical trials to assess its safety and performance in creating LASIK flaps.
LenSx Laser has one completed clinical trial, NCT01556893, titled 'Creating LASIK Flaps With the LenSx Femtosecond Laser.' This Phase 1 study enrolled 20 participants in Hungary and evaluated the device in patients with myopia and hyperopia. The trial was uncontrolled and not randomized.
LenSx Laser is a femtosecond laser system designed to create corneal flaps during LASIK surgery. It uses ultra-fast laser pulses to precisely cut corneal tissue, enabling the surgeon to lift a thin flap and reshape the underlying cornea to correct refractive errors such as myopia and hyperopia.