Technolas Perfect Vision unveils two new pioneering laser procedure innovations

It’s an exciting period for TPV, having recently unveiled our latest pioneering laser procedures for cataract surgery and presbyopia during the ESCRS in Paris. First, TPV announced its new femtosecond laser cataract procedure called CUSTOMLENS™. This new procedure will be available on the TECHNOLAS Femtosecond Workstation. The CUSTOMLENS procedure has been developed to assist the surgeon to perform the key steps in cataract surgery; anterior capsulotomy, lens fragmentation, limbal relaxing incisions and clear corneal incisions. The clinical benefits include greater control and more precision compared with performing these steps manually.

The Only All-In-One Cataract and Refractive Femtosecond Laser

The CUSTOMLENS is the latest procedure to become available on the TECHNOLAS Femtosecond Workstation, which already provides the intrastromal treatment for presbyopia, INTRACOR^®, the CUSTOMFLAP^® module and CUSTOMSHAPE^® for therapeutic indications. Unlike other competitor femtosecond systems, Technolas Perfect Vision is the only company which is able to provide customers with the option for both the cataract and refractive procedures to be available on one single femtosecond laser. In addition, a stand-alone cataract femtosecond laser will also be available.

SUPRACOR - New Excimer-based Presbyopia treatment

TPV also unveiled its new excimer-based treatment for presbyopia, called SUPRACOR™, during the ESCRS. SUPRACOR is an aberration-optimised presbyopic algorithm which is designed to be applied to hyperopic, emmetropic and myopic eyes, as well as post-LASIK eyes. The SUPRACOR treatment is performed using the TECHNOLAS Excimer Workstation 217P.

A New Approach to Treating Presbyopia

The SUPRACOR algorithm uses a new methodology in treating presbyopia. It combines TPV’s learnings from the surface approach with the excimer laser, with the growing knowledge from the intrastromal presbyopic INTRACOR treatment, and successfully extended this INTRACOR concept to all people by applying it to our excimer platform. This novel approach has resulted in a presbyopic treatment which provides the expected near addition without inducing undesired aberrations. Initial findings from the clinical investigations on SUPRACOR, which were presented during the recent international congresses, show high patient satisfaction and excellent outcomes. [Read the congress highlights for more information on the clinical outcomes].

TPV’s Complementary Presbyopia Platform

TPV is now able to offer customers and patients a comprehensive treatment approach to presbyopia with INTRACOR and SUPRACOR. Now, with the availability of SUPRACOR, the benefits of INTRACOR are extended to the widest range of ametropes using the excimer technology. During TPV’s ESCRS symposium, when the audience were asked to vote on whether they believe presbyopia correction will be important for their practice, 93% said it would be either very important or important. Furthermore, 79% believed TPV would play an important role in increasing their presbyopic patient volume, with three quarters agreeing SUPRACOR and INTRACOR would open the door to a significant market opportunity.

European Region
ESCRS Symposium Highlights, Paris

First clinical cases with new CUSTOMLENS femtosecond cataract procedure

“CUSTOMLENS is very promising procedure for cataract surgery and can provide precision and control for the cataract steps”, according to Prof Gerd A Auffarth, Acting Chairman of the Ophthalmology Department, the University of Heidelberg, Germany. Prof Auffarth shared his first clinical experience with the new CUSTOMLENS procedure for femtosecond laser cataract surgery, during TPV’s Lunchtime Symposium at the ESCRS in Paris. Prof Auffarth already has experience using the TECHNOLAS 520F for the INTRACOR procedure and for therapeutics indications, so was very interested to use the new CUSTOMLENS module for cataract surgery. Following initial laboratory evaluations, Prof Auffarth then joined Dr Luis Ruiz, in Bogota, Colombia to commence the first cases with the CUSTOMLENS module. To-date, around 50 cases have been conducted.

Explaining the CUSTOMLENS Module in practice, Prof Auffarth demonstrated how after first selecting the CUSTOMLENS module from the main menu of the graphic user interface (GUI), this brings the surgeon to the CUSTOMLENS GUI (as shown in Figure 3).
The CUSTOMLENS GUI allows the user to select the specific steps of the cataract procedure: Capsulotomy, Lens Fragmentation, or LRI/AK. One key feature of the software is the online optical coherence tomography which provides a real-time view of the procedure during planning and treatment.

Whilst showing some of the video footage of the clinical experience, Prof Auffarth commented on the high level of accuracy and predictability of the capsulorhexis that can be achieved with CUSTOMLENS. Clinical evaluations of the lens fragmentation have explored different fragmentation patterns, with initial results indicating the radial cut pattern to be a more optimised approach (Figure 4). In addition to the control and precision achieved with the femto-cataract procedure, this method of lens fragmentation can potentially reduce the phaco energy used to remove the cataract following lens fragmentation, plus possibly allow for better placement of the intraocular lens.

First clinical results with the SUPRACOR algorithm for presbyopia

Dr Jorge Castanera, from Barcelona, Spain, also presented the first clinical outcomes from the European Multicentre study on TPV’s new excimer treatment for presbyopia, SUPRACOR, during the ESCRS. SUPRACOR is a new corneal approach to treat presbyopia using the TECHNOLAS Excimer Workstation 217P. Dr Castanera described how the algorithm combines the INTRACOR learnings with the best of the experience from TPV‘s excimer-based algorithms. Using this approach, good near, intermediate and distance vision can be achieved. The SUPRACOR approach can be combined with Tissue Saving for Hyperopia and ZYOPTIX Aspheric for Myopia. Emmetropic eyes as well as post-LASIK cases are also under investigation, which Dr Castanera considers to be an important advance over other technologies. In this bilateral treatment, the same treatment profile is applied to both eyes, so there is no monovision.

The European Multicentre CE study is being conducted at 4 sites in Europe: Dr Jean-Jacques Chaubard, Dr Antoine Roure, both from Nice, Dr Dominique Pietrini from Paris, and Dr Jorge Castanera from Barcelona. Describing the advantages of this new presbyopia treatment, Dr Castanera explained how unlike other presbyopic algorithms which create aberrations inside the pupil region, SUPRACOR provides the near addition while minimising the induction of undesired aberrations. This should improve the quality of vision for distance and for near. A simulation of the retinal images generated from corneal topographies integrated into Ray-Trace-Software for objects in near, intermediate and distance positions demonstrates the maintenance of good quality of vision across an expanded treatment range, including distance vision using the aberration optimised SUPRACOR treatment.

The one month results from the multicentre study were presented in Paris. All patients were over 50 years old so they are fully presbyopic, with a mean patient age of 56 years. Following a nomogram adjustment in the first 6 patients, 82.4% of subsequent study patients (34 eyes) achieved an uncorrected binocular uncorrected near visual acuity of 1.0 decimal (J1), with 90% at 0.80 decimal or better (J2). For binocular uncorrected distance visual acuity, 52.9% of patients were 1.0 decimal or better, and 82.4% were 0.8 decimal or better (Figures 6a and b). Further 3 and 6 month data, which will be presented at forthcoming congresses, find the results improve slightly, both for distance and near vision.

High level of patient satisfaction

Part of the CE study involved a subjective patient questionnaire, which found that 100% of patients could read the newspaper, menus and short text message. Eighty eight percent could read the text on package inserts. All patients could also use the computer without glasses. Overall, all the patients completing the survey said they would recommend the procedure, with all patients feeling comfortable without glasses both indoors and outdoors.

Dr Castanera considers SUPRACOR to be a step forward in the treatment of presbyopia. Like all treatments, good patient selection and counselling is required, setting realistic expectations. Glasses independence is achieved in a very high percentage of cases. As SUPRACOR is using well-known LASIK technology, there is no steep learning curve.

Other symposium highlights

Two year results show INTRACOR remains stable
Prof Mike Holzer, from the Department of Ophthalmology, University of Heidelberg presented the 2-year follow-up data from the INTRACOR CE study. A subgroup of 25 patients requiring a near addition of +2.00D underwent the INTRACOR procedure in the non-dominant eye, at the Heidelberg site. Two year data on 17 patients shows refractive outcomes remain stable out to 24 months. UCNVA was 0.2 logMAR at 24 months versus 0.70 logMAR preoperatively. Most patients gained between 4 and 5 lines of near visual acuity. No regression or ectasia has been observed.

CUSTOMFLAP provides predictable and high quality flaps
Reporting on his experience on 50 eyes undergoing the flap procedure with the CUSTOMFLAP module on the 520F, Dr Federico Alonso said consistent, high quality and predictable flaps were created. For an intended flap diameter of 9.5mm, the mean achieved flap diameter was 9.25 mm (2.63 % maximum variation). For the intended flap thickness of 120μm, the mean achieved flap thickness was 118μm or 112μm, when measured with either the OCT Visante or the Pachymeter, respectively. All flaps were within 15μm of the intended thickness.

Broad range of therapeutic indications with CUSTOMSHAPE
Dr Louis Hoffart, from Hôpital de la Timone, Marseille, France, demonstrated the expansive range of therapeutic indications which can be performed with CUSTOMSHAPE. Video footage included anterior lamellar keratoplasty (ALK), decagonal shape keratoplasty, endothelial keratoplasty, AK cuts and post-keratoplasty wedge resection.

To learn more about these procedures and view all of TPV’s ESCRS lunchtime symposium presentations, visit: http://www.technolaspv.com/media/presentations/presentations_100183_0.html

Asian Region
APAO, Beijing

Indications beyond INTRACOR

The soft, thin suction ring used for LASIK flaps performed with the 520F is beneficial to Asian eyes, according to Dr Vincent Lee, Hong Kong Laser Eye Centre, Hong Kong. Dr Lee presented his initial CUSTOMFLAP experience using the 520F, during TPV’s APAO Alliance meeting in Beijing. Dr Lee also considers the spiral out-to-in ablation pattern assists patient fixation to be an advantage to the procedure, especially in nervous young patients, as there is less likelihood of visual blackout.

Dr Luis Ruiz, from Colombia, Bogota, gave a glimpse into future indications with intrastromal femtosecond patterns. Currently, work is underway to combine the correction of presbyopia with the correction of astigmatism. To-date, clinical evaluations have demonstrated excellent outcomes, treating patients with with astigmatism as high as 1.50D, using a number of different treatment patterns including an elliptical shaped ring pattern. In the future, other treatment possibilities will be considered using the same femtosecond laser.

US Region
AAO TPV Alliance Meeting

First US Experience with the TECHNOLAS 520F for Flaps

With the recent US-launch of the system, the Fichte, Endl, and Elmer Eyecare clinic, based in Buffalo, is the first US practice to use the TECHNOLAS Femtosecond Workstation 520F for flaps, displacing a competitor system. The practice is now routinely using the CUSTOMFLAP module. Dr Mike Endl discussed his initial clinical experience using the femtosecond laser during TPV’s Alliance User Meeting, during the AAO in Chicago.

The practice has recently commenced a contralateral clinical study which is a contralateral flap comparison between the TECHNOLAS 520F and the Intralase. The study is in the early stages, but a trend towards a substantial difference in the level of redness, inflammation, and conjunctival haemorrhaging at day one post-op has been observed (See Figure 7). Dr Endl attributes this difference to the curved patient interface on the TECHNOLAS 520F which does not applanate the eye, so leading to a reduced increase in IOP. IOP measurements conducted at the practice found the 52OF IOP increased by 40mmHg compared with an IOP increase of 65-70mmHg recorded with the applanating patient interface approach (Intralase).

i) Left: Day #1 Post-Op Flap Creation with TECHNOLAS 520F CUSTOMFLAP ii) Right: Day #1 Post-Op Flap Creation with Intralase