A Comparative Study Of The Efficacy And Safety Of A Novel Endocapsular Device Combined With A Multifocal Iol In 150 Patients

This study investigates and compares the optical performance and safety of a novel endocapsular device (fixOflexTM) in patients who had a bilateral cataract operation and used in combination with a Panoptix IOL versus the same multifocal IOL implanted alone in a control group of patients.

This single-center, non-randomized prospective study at ASUKA Eye Clinic (May 2022–March 2024)

150 patients undergone a bilateral cataract surgery with the novel endocapsular device and Panoptix IOL (Group 1) and 150 patients with a multifocal IOL alone (Group 2). Preoperative and postoperative (1 week, 1 and 3 months) assessments included visual acuity (5 to 0.3m), slit-lamp exam, contrast sensitivity (mesopic/ photopic conditions), IOP, flare values, endothelial cell density, and patient-reported outcomes (VFQ-25, Multifocal IOL Questionnaire).

The study found a spherical equivalent (SE) of -0.15 ± 0.43 D in Group 1 and -0.33 ± 0.41 D in Group 2. Both groups had similar UCVA, but Group 1 performed significantly better at 1m (p=0.0276) and 0.3m (p=0.0288). In CDVA and bilateral UCVA  Contrast sensitivity was superior in Group 1 under both mesopic and photopic conditions. Spectacle indipendence was higher in Group 1 for both intermediate and near vision (p=0.011, p=0.0037). Group 1 also showed advantages in peripheral vision, near activities, and overall satisfaction. Safety outcomes were comparable between groups and according to the literature.

The combination of the novel endocapsular device with a multifocal IOL resulted in improvements in intermediate and near visual acuity, contrast sensitivity, and reduced spectacle dependence for near and intermediate distances. These findings suggest that the device may enhance functional visual outcomes, as reflected in improved peripheral visual function and higher patient-reported satisfaction with near and intermediate vision. Further studies with longer follow-up and larger sample sizes are warranted to confirm these results and assess long-term safety and efficacy.