Long-Term Visual Performance And Stability Of The Evolux Intraocular Lens: A 12-Month Follow-Up Study

This study aims to evaluate visual outcomes, refractive stability and long-term visual performance of the novel non-diffractive extended monofocal intraocular lens (Evolux, Sifi) following cataract surgery over a 12 month follow-up period. A key objective was to compare visual acuity parameters at different postoperative time points (3 and 12 months) to determine the stability and evolution of visual performance over time. SIFI’s EVOLUX^® is an advanced monofocal IOL featuring a fully non-diffractive optical profile, designed to combine the simplicity and clarity of the traditional monofocal lenses, while extending functional vision acuity, particularly at intermediate distances, ranging from 80 to 40 cm. 

Onioptic Hospital of Ophthalmology, Craiova, Romania

We conducted a single-arm, non-randomized, retrospective study at Onioptic Hospital, Craiova, Romania, involving patients who underwent cataract surgery from November 2022 to November 2023. Monocular uncorrected (UDVA) and distance-corrected distance visual acuity at distance (UDVA/CDVA), intermediate (UIVA/DCIVA) and near (UNVA/DCNVA) and postoperative refraction expressed as spheric equivalent (SE) were assessed at 3 and 12 months postoperativelhy. The contrast sensitivity and defocus curve were evaluated at 12 months postoperatively in 28 patients who underwent surgery in both eyes. 

A total of 103 lenses were implanted in 75 patients, including 28 who received bilateral implants. At 12 months, 72.82% of eyes achieved an UDVA of LogMAR 0.05 or better, with 82.52% of eyes had CDVA of LogMAR 0 or better. UIVA of logMAR 0.1 or better significantly improved from 8.7% at 3 months to 24.27% at 12 months (p = 0.005). UNVA and DCNVA achieved LogMAR 0.4 or better in 80.99% and 83.50%, respectively. The defocus curve confirmed functional vision across a continuous range of 2.0D, ensuring good intermediate vision from 60 cm to 1 meter. The SE predictability was high, with 81.37% of the eyes within ±0.50 D of the target refraction, and 51.5 % within SE ± 0.25D. 

The Evolux IOL exhibited very good biometric predictability and visual performance, providing excellent distance vision, stable intermediate vision, and good functional near vision. With no reported photopic side effects or glare, it surpasses expectations for this category of lenses, while maintaining optical efficiency and a quality of vision comparable to standard monofocal IOLs.