SIFI’s Ultimate Vision: Mastering Sight with Wavefront Engineering and Innovative Ocular Surface Management

by Tan Sher Lynn and Gloria D. Gamat

On Day 4 of the 42nd Congress of the European Society of Cataract and Refractive Surgeons (ESCRS 2024), SIFI (Catania, Italy), in a special symposium, highlighted the company’s groundbreaking wavefront engineering technology that is designed to elevate intraocular lens (IOL) performance across all visual distances.

Insights on advanced biometry and constant optimization

As the first speaker, Dr. Savini presented advanced biometry techniques, emphasizing the critical role of precision in achieving optimal outcomes with extended monofocal IOLs, such as the EVOLUX®. Also, he highlighted the necessity of validating preoperative measurements and using more than one optical biometer to ensure precision. Constant optimization, another crucial factor, was discussed in detail. 

“For better outcomes, you should validate your measurements, use more than one optical biometer and to optimize your process – this is an ongoing effort that never stops. We have to make accurate calculations and be aware of the refractive outcomes… that we are not perfect, and that should be communicated to the patients,” explained Dr. Savini.

Dr. Savini also stressed the importance of using modern IOL calculation formulas like Barrett Universal II and EVO 2.0. However, despite technological advancements, achieving 100% accuracy remains elusive, with current IOL power calculations meeting the target within 0.5 D in 70-80% of cases. “Because sometimes even the best biometer can make wrong measurements. And not all biometers are fully interchangeable. The best method in my opinion is the ESCRS IOL calculator because this has the most modern formula and the most accurate one,” he added. 

Dr. Savini noted that these steps are crucial for improving the accuracy of IOL power calculations and enhancing overall patient satisfaction. “Focus on preoperative measurements, cross-check data from multiple devices, and refine the constants used in IOL formulas,” Dr. Savini concluded.

Comparative clinical evaluation: EVOLUXⓇ vs. TECNIS EyhanceTM IOLs

In a comparative clinical evaluation, Prof. Oliver Findl (Austria) and his team at the Vienna Institute for Research in Ocular Surgery (VIROS) assessed the performance of the SIFI EVOLUX® IOL against the TECNIS EyhanceTM IOL (Johnson & Johnson Vision). This single-center, randomized, double-masked, controlled trial included 35 participants (70 eyes), with each eye receiving either the EVOLUX® or TECNIS EyhanceTM lens. The study focused on visual outcomes, including near (40 cm), intermediate (66 cm)and distance (4 m) vision, as well as contrast sensitivity, glare and halo measurements.

The findings revealed that both IOLs delivered comparable distance and intermediate vision performance. By the 3-month mark, contrast sensitivity and photic phenomena outcomes also showed minimal differences between the two lenses, further underscoring their similarity in performance.

Overall, the EVOLUX® IOL demonstrated very similar visual outcomes to the TECNIS EyhanceTM, making it a viable option for patients seeking enhanced vision post-cataract surgery.

“The perceived vision at near was actually a little better for the SIFI eyes, but it was not statistically significant. Over-all, the patients did not see any difference between the two eyes (EVOLUX® vs TECNIS EyhanceTM),” Prof. Findl noted.

EVOLUXⓇ long term clinical outcomes show positive results in patients

Dr. Kresimir Gabric’s eye clinic in Zagreb, Croatia (Eye Clinic Svjetlost Zagreb) has implanted more than 25,000 presbyopia-correcting since 1999 and has explored many IOL platforms. “In the last four years alone, we have implanted more than 8,000 premium IOLs,” Dr. Gabric shared. Dr. Gabric presented clinical long-term results on a large number of patients with the new EVOLUX® IOL platform. “Over 12 months ago we analyzed 230 eyes with a mean follow-up of 6 months,” shared Dr. Gabric.

In highlighting some of the most important points of the outcomes, Dr. Gabric presented data demonstrating that the EVOLUX® maintained contrast sensitivity, indicating that the lens not only showed good vision in normal lighting, but also maintained quality of vision in challenging lighting conditions. 

“EVOLUX® is a great new addition to the IOL portfolio offering great uncorrected vision for distance and intermediate needs, with some usable near visual acuity,” added Dr. Gabric. Our experience with implantations and follow-ups shows great patient satisfaction and low patient reported issues with the lens. EVOLUX®, for us, represents a fundamental shift in standard of care,” he concluded. 

WELL FusionⓇ System outperforms trifocal IOLs in presbyopia correction

Prof. Emilio Pedrotti (Italy), discussed the performance of extended depth of focus (EDoF) IOLs versus trifocal IOLs in patients undergoing bilateral implantation.

“The idea to combine two different IOLs in both eyes in order to achieve a better extended depth of focus is not new. And when SIFI proposed this system – two IOLs that share the same platform, I was convinced,” Prof. Pedrotti shared. 

According to Prof. Pedrotti, the WELL Fusion® System combines two EDoF non-diffractive IOLs (Mini WELL® and Mini WELL PROXA®). Patients with the WELL Fusion® System reported high visual acuity at all distances, from near to far, and exhibited continuous vision up to 33 cm. The WELL Fusion® System also provided an extended depth of focus of 4.5 D, allowing for complete presbyopia correction.

Notably, patients implanted with the WELL Fusion® System experienced higher satisfaction rates, with a significant reduction in glare and other photic phenomena compared to those with trifocal IOLs. Additionally, the WELL Fusion® System achieved higher spectacle independence, allowing patients to perform daily activities with minimal reliance on corrective eyewear.

Overall, the WELL Fusion® System demonstrated superior performance in terms of visual outcomes and patient satisfaction, making it a highly effective option for presbyopia correction in cataract surgery.

“In conclusion, the WELL Fusion® System showed significantly better results in terms of quality of vision in both objective and subjective performances and with higher patient satisfaction,” Prof. Pedrotti summarized. 

Optimizing ocular surface health for better cataract surgery outcomes

In modern cataract surgery, taking care of the ocular surface is essential for ensuring positive outcomes. According to Prof. Rita Mencucci from the University of Florence (Italy), comprehensive pre- and postoperative therapies, including NSAIDs, antiseptics, lubricants and steroids, play a pivotal role in patient recovery. However, complications such as dry eye disease (DED), inflammation and infection remain concerns, potentially leading to discomfort and reduced visual outcomes.

Cataract surgery-related dry eye stems from inflammation, hyperosmolarity and tear film instability, which disrupt ocular surface homeostasis. Prof. Mencucci highlighted that up to 50% of patients undergoing cataract surgery show signs of corneal damage and reduced tear stability. Addressing these issues through innovative treatments, like dual polymer lubricating eye drops containing osmoprotectants, can improve tear film stability and alleviate dry eye symptoms.

“The end of the operative period is the beginning of the real nightmare, not just for the patient, but for the surgeon too. It is a postoperative discomfort,” emphasized Prof. Mencucci. 

Postoperative management also involves controlling inflammation and preventing infections. The use of antibiotics, especially intracameral cefuroxime and moxifloxacin, has proven effective in reducing endophthalmitis risk. Emerging treatments, such as ophthalmic gels based on xanthan gum, offer additional benefits by enhancing ocular hydration and wound healing.

Ophthalmic hydrogel formulations containing netilmicin/dexamethasone have demonstrated efficacy and safety in treating inflammation and preventing infection after cataract surgery. In addition, she shared a study that demonstrated that xanthan gum 0.2% + desonide sodium phosphate 0.025% eye drops were effective in reducing ocular surface disease symptoms and signs after cataract surgery.

“As a new solution, the inclusion of xanthan gum in ophthalmic solutions increases the satisfaction in both patient and surgeon,” concluded Prof. Mencucci.

Posters and papers presented at ESCRS 2024

Dr. Victor Caparas and his team from The Medical City (Manila, Philippines), presented data at an ESCRS poster session on long-term visual outcomes following the implantation of EVOLUX® in twenty-three patients (46 eyes). Their evaluation compared these long-term results to the immediate postoperative period.

Results showed that at both the early (90-105 days) and long-term (6-12 months) postoperative periods, bilateral implantation of the extended monofocal EVOLUX® IOL led to excellent distance vision, very good extended intermediate vision and very good near vision. The quality of vision was notably high, as reflected by strong contrast sensitivity and a low incidence of photic phenomena. Additionally, high scores on the (Quality of Vision) questionnaire confirmed strong patient acceptability and satisfaction.

Similarly, preliminary outcomes of EVOLUX® IOL patients presented by Dr. Giovanni Romualdi and Prof. Rita Mencucci in another poster at ESCRS 2024 shows good refractive accuracy and visual outcomes after cataract surgery. 

Furthermore, data from an ESCRS 2024 poster presented by Dr. Savini and colleagues demonstrated that a new enhanced monofocal IOL (EVOLUX®) provides patients with improved DCIVA and DCNVA compared to the standard monofocal IOL with no loss of contrast sensitivity and no subjective visual disturbances.

In a cataract poster at ESCRS 2024, Dr. C. Pagnacco and colleagues from the University of Verona (Italy), presented data demonstrating the visual performance in terms of quality of vision and visual outcomes after bilateral implantation of extended monofocal IOL. Twenty patients (40 eyes) underwent bilateral implantation of EVOLUX®. EVOLUX® IOLs demonstrated a good safety profile and excellent visual performance at all distances. Patients had very good contrast sensitivity and high satisfaction in both objective and subjective evaluations of vision. Importantly, no patient needed YAG-laser capsulotomy.

In addition, Dr. Mercedes Molero-Senosiain and colleagues from Hospital Clínico San Carlos (Madrid, Spain), presented a poster at ESCRS 2024 reporting on the outcomes of a new ophthalmic solution containing sodium hyaluronate, osmoprotectants and xanthan gum in patients with dry eye disease (DED) after three months of treatment. The study demonstrated that this preservative-free solution significantly improved signs, symptoms, and quality of life in DED patients, with noticeable improvements observed as early as one month into treatment.

Editor’s Note: Reporting for this story took place at the 42nd Congress of the European Society of Cataract and Refractive Surgery (ESCRS 2024), held from 6-10 September in Barcelona, Spain.