WaveLight Plus Innoveyes
 | This article appears to have been generated by a large language model (such as ChatGPT) without having been rigorously scrutinized for verifiability, neutrality, original research, and copyright compliance. It may include misleading or inaccurate claims and fake references that sound plausible. (Learn how and when to remove this template message) |
| WaveLight Plus Innoveyes | |
|---|---|
| File:WaveLight Plus system.jpg The WaveLight Plus (InnovEyes) refractive surgery platform (illustrative). | |
| Synonyms | InnovEyes Sightmap LASIK |
| Specialty | {{#statements:P1995}} |
| Inventor(s) | WaveLight GmbH (Erlangen, Germany) |
| Manufacturer | Alcon (WaveLight GmbH) |
| Related items | WaveLight EX500, WaveLight FS200, Wavelight Topolyzer Vario |
[[[d:Lua error in Module:Wikidata at line 863: attempt to index field 'wikibase' (a nil value).|edit on Wikidata]]] | |
WaveLight Plus (InnovEyes) is an ophthalmic laser platform for performing fully customised LASIK (laser-assisted in situ keratomileusis). It uses the InnovEyes Sightmap diagnostic device to capture comprehensive ocular measurements (wavefront aberrometry, corneal topography and biometry) and generate a detailed three-dimensional “digital eye twin”【41†L48-L54】【23†L13-L21】. A proprietary ray-tracing algorithm then calculates a patient-specific ablation profile. The system includes a femtosecond laser (WaveLight FS200) for creating the corneal flap and an excimer laser (WaveLight EX500) for the tissue ablation, with advanced eye-tracking and alignment【66†L188-L193】【85†L78-L86】.
WaveLight Plus (InnovEyes) was first introduced in China in late 2023, with subsequent launches in Europe and other regions【15†L121-L124】【41†L75-L83】. It received European CE marking (class IIb) in November 2019【30†L19-L27】 and U.S. FDA approval (PMA P020050/S043) on 5 March 2025【85†L78-L86】. The system is indicated for LASIK correction of myopia (spherical equivalent −1.0 to −9.0 D) with or without astigmatism (up to 3.0 D)【85†L78-L86】, in adult patients with stable refraction. In published series, nearly all treated eyes attained 20/20 uncorrected vision: for example, a 2023 study (n = 400 eyes) found 100% of eyes achieved UDVA ≥20/20 at 3 months【23†L21-L29】, and a 2024 multicentre study (n = 212 eyes) reported 98.1% reaching ≥20/20【29†L36-L44】.
History
WaveLight AG was founded in Erlangen, Germany in 1996 to develop high-speed excimer lasers and diagnostics for refractive surgery【38†L115-L123】. In 2007, Alcon Inc. (Fort Worth, TX) announced a friendly takeover of WaveLight, integrating its Allegretto laser technology into Alcon’s portfolio【38†L115-L123】. Early research on ray-tracing algorithms for LASIK planning was reported by Mrochen et al. (2008) and Schumacher et al. (2012)【33†L199-L208】. Alcon continued this work, and by 2019 the InnovEyes Sightmap diagnostic device (for wavefront-guided ablation using ray tracing) was CE-marked in Europe【30†L19-L27】. The first clinical launches of WaveLight Plus (InnovEyes) occurred in China (December 2023) and select Asia-Pacific/European centres【15†L121-L124】【41†L75-L83】. The U.S. FDA granted premarket approval for WaveLight EX500 with InnovEyes on 5 March 2025【85†L78-L86】, allowing commercial use in North America.
Design and Technology
The WaveLight Plus system integrates multiple components: the InnovEyes Sightmap diagnostic device captures over 100,000 data points by measuring the patient’s ocular wavefront, corneal tomography and biometric parameters【41†L48-L54】【23†L13-L21】. These data feed into a ray-tracing algorithm that models the entire optical pathway of the eye. The resulting ablation plan aims to correct both lower- and higher-order aberrations in a single customised LASIK treatment. A WaveLight FS200 femtosecond laser creates a corneal flap (in ~6 seconds per flap)【66†L188-L193】, and the WaveLight EX500 excimer laser performs rapid 500 Hz ablation of the corneal stroma. The EX500 features a 1050 Hz eye tracker and Z-axis alignment to enhance accuracy【70†L189-L194】【85†L78-L86】. The system operates through proprietary software interfaces for treatment planning and laser control.
【63†embed_image】 *Figure: InnovEyes (Sightmap) diagnostic device used to capture comprehensive ocular measurements for WaveLight Plus personalized LASIK.*
Clinical applications
WaveLight Plus (InnovEyes) is indicated for primary LASIK correction of myopia and myopic astigmatism within its approved range【85†L78-L86】. Specifically, U.S. FDA labeling covers spherical equivalent −1.00 D to −9.00 D and up to 3.00 D of cylinder【85†L78-L86】. Patients must be ≥18 years old with stable refractions (≤0.50 D change in 1 year and agreement within 0.75 D between manifest and Sightmap measurements). The procedure is intended for standard flap-based LASIK only (not PRK or SMILE). As with any LASIK, patients with thin corneas, irregular topography (e.g. keratoconus) or other contraindications are excluded. In practice, WaveLight Plus is used in clinics where the full Wavelight Refractive Suite (EX500 + FS200 + Topolyzer + InnovEyes) is available.
Regulatory approvals
WaveLight Plus (InnovEyes) holds approvals in multiple regions:
| Region | Authority/Notation | Date | Key indications |
|---|---|---|---|
| United States | FDA (PMA P020050/S043) | 5 Mar 2025 | Myopia up to −9.00 D (≤3.00 D astigmatism); standard LASIK indications【85†L78-L86】 |
| European Union/UK | CE mark (class IIb) | Nov 2019 | CE certificate for InnovEyes Sightmap device【30†L19-L27】 (used in customised LASIK) |
| China | NMPA (de facto) | 2023 | Introduced in December 2023 (approved for refractive surgery)【15†L121-L124】 |
| Canada | Health Canada | 2025 | Commercial launch late 2025 (presumed approval in line with FDA)【41†L75-L83】 |
(CE: European Conformity; NMPA: China’s National Medical Products Administration.) The U.S. FDA summary of safety and effectiveness outlines the approved range of corrections【85†L78-L86】. No mandatory recalls or safety withdrawals of the WaveLight EX500 or InnovEyes components have been reported【11†L1-L4】.
Clinical evidence
Peer-reviewed studies of WaveLight Plus (InnovEyes) report excellent visual outcomes. He and Bala (2023) retrospectively reviewed 400 eyes treated with ray-tracing LASIK and found 100% achieved 20/20 uncorrected vision by 3 months (and 89% achieved ≥20/16)【23†L21-L29】. A 2024 international multicentre post-market study (212 eyes) found 98.1% attained ≥20/20 at 3 months【29†L36-L44】. That study also noted 83% of eyes achieved 20/16 or better, a higher proportion than typically seen with conventional wavefront- or topo-guided LASIK【31†L763-L772】. Patient satisfaction has been reported as very high (99.1% satisfied in one series)【30†L84-L90】.
| Study | Design | Sample | Key results (3-month UDVA ≥20/20) | Reference |
|---|---|---|---|---|
| He & Bala 2023 | Retrospective case series (ray-trace LASIK) | 400 eyes | 100% of eyes (89% ≥20/16)【23†L21-L29】 | |
| Kanellopoulos et al. 2024 | Prospective multicentre study | 212 eyes | 98.1% of eyes【29†L36-L44】 | |
| NCT04219891 (Pivotal trial) | Prospective FDA trial (bilateral InnovEyes LASIK) | 374 eyes | Results reported in Kanellopoulos 2024 (see above) | |
| NCT07084844 (Mann Eye Institute) | Prospective observational (patient-reported outcomes) | 52 pts | Outcomes under evaluation (quality-of-life, satisfaction) |
Safety and adverse events
No novel safety issues have emerged for the WaveLight Plus system beyond the known risks of LASIK surgery. In the Kanellopoulos et al. study, only two serious adverse events (neither related to flap creation) were reported, and both were judged not related to the device【30†L84-L90】. FDA records indicate that neither the EX500 laser nor the InnovEyes Sightmap have been withdrawn or recalled for safety reasons【11†L1-L4】. Common LASIK complications – loss of best-corrected vision, new visual symptoms (glare, halos, double vision), under- or overcorrection, and dry eye – remain potential risks【54†L131-L139】【54†L145-L153】. As with any LASIK procedure, patient screening and surgical technique are critical to minimise risks.
Market adoption
WaveLight Plus (InnovEyes) is in early adoption by refractive surgeons worldwide. After initial use in Asia-Pacific and Europe, it became available in North America in late 2025【15†L121-L124】【41†L75-L83】. Leading ophthalmology centres in the U.S. and Canada have begun offering the technology. Manufacturer statements suggest strong interest from surgeons, but comprehensive market penetration data are not yet published. The technology competes in a mature LASIK market dominated by well-established excimer lasers and diagnostic systems.
Competitors
Other advanced LASIK platforms offer customised ablation profiles. Johnson & Johnson Vision’s iDESIGN Refractive Studio (Wavefront-guided LASIK) and Alcon’s own Contoura Vision (topography-guided LASIK) are the main alternative systems. Companies such as Bausch+Lomb/Schwind (Amaris lasers) and Carl Zeiss Meditec also sell high-frequency excimer lasers with similar capabilities. These systems differ in their measurement devices and algorithms; no head-to-head trials between InnovEyes and competitors have been published.
References
External links
- ClinicalTrials.gov: WaveLight EX500 (InnovEyes) LASIK pivotal trial (NCT04219891)
- ClinicalTrials.gov: Patient Outcomes with WaveLight Plus LASIK (NCT07084844)
- FDA PMA P020050/S043 – WaveLight Plus InnovEyes LASIK (Summary of Safety and Effectiveness)
Category:LASIK Category:Alcon Template:Ophthalmology-stub
This article "WaveLight Plus Innoveyes" is from Wikipedia. The list of its authors can be seen in its historical and/or the page Edithistory:WaveLight Plus Innoveyes. Articles copied from Draft Namespace on Wikipedia could be seen on the Draft Namespace of Wikipedia and not main one.
