CLINICAL SAFETY AND EFFICACY OF A NOVEL INTRACAPSULAR RECONSTRUCTOR (FIXOFLEXTM) IN A REAL-WORLD POPULATION: A 6-MONTH FOLLOW-UP PROSPECTIVE STUDY

Published 2024 - 28th ESCRS Winter Meeting

Reference: P195 | Type: Submission | DOI: 10.82333/pyfk-2528

Authors: Emmanouil Xylouris* ¹ , Ioannis Pallikaris ¹ , Santaro Noguchi ²

¹Medical School, University of Crete,Institute of Vision and Optics,Heraklion,Greece, ²ASUCA Eye Clinic Sendai,Sendai,Japan

Purpose

This prospective study evaluated the visual, refractive, and safety outcomes of an intracapsular reconstructor 6 months after implantation in combination with an intraocular lens (IOL) in cataract.

Setting

ASUCA Eye Clinic (Sendai Mark One)

Methods

Cataract patients presented at ASUCA Eye Clinic (Sendai Mark One) between April 2022 and April 2023 were enrolled in the study, having undergone crystalline lens extraction by phacoemulsification and implantation of a fixOflex^TM in combination with an IOL. Preoperative, 1-week, 1-month 3-month, and 6-month postoperative data was collected. The examination included: monocular uncorrected (UDVA) and best-corrected distance visual acuity (BCDVA), slit-lamp examination, optical biometry, intraocular pressure (IOP), flare values, endothelial cell count, and postoperative complications.

Results

60 eyes of 45 patients were analyzed. Six months after the surgery, mean postoperative BCDVA was -0.06 ± 0.13 logMAR, and mean UDVA 0.06 ± 0.18 logMAR. The fixOflex^TM and IOL were stable in the capsular bag as demonstrated by tilt and decentration measurements. IOP, corneal status, endothelial cell count values, and flare values were in the normal range. Posterior capsular opacification was observed in 1 patient. Nd:YAG treatment was not performed on any patient.

Conclusion

This study indicates excellent post-operative visual acuity and refractive outcomes in eyes after FixOflex^TM implantation. This is accompanied with very little risk of intraoperative and postoperative complications.