Title: Long Term Follow-Up With The The Fixoflex Ring

Purpose: To report on the clinical outcomes of 120 implantations of the fixOflex ring in cataract patients (mean age 63.53 years, SD 8.28 years) with follow up ranging from 12 months to 36 months. 

1 Department of Medicine, University of Crete, Heraklion, ² Research, EYE-PCR B.V., Heraklion,  3 Ophthalmology, Alexandria University, Alexandria, Egypt 

Methods: The fixOflex ring fills the capsular bag and features special retainers (clips) to lock the Intraocular Lens (IOL) optic concentric to the capsular bag equator. It is implanted via a 2.4mm injector. One hundred and twenty (120) patients were randomly recruited and received the ring in combination with a Tecnis (ZCB00) (Johnson And Johnson New Brunswick, NJ) IOL following standard biometry using the Haigis formula. Follow up intervals included one day, one week, one month, three months, six and twelve months postoperatively. 

Results: Mean Best Spectacle corrected Visual Acuity after 12 months was 0.95 (SD 0.12). Mean refractive surprise (difference from target refraction) was -0.35 D at 12 months postoperative interval. Refraction was stabilised (no statistical difference between corresponding intervals) after the 3 months interval. None of the patients has developed posterior capsule opacification (PCO) requiring intervention in the study period. No serious adverse events were observed during or after implantation.

Conclusions: The Fix-o-flex ring provides an open capsule space for IOL implantation. Current IOL haptic designs not always fulfill the correct axial placement and perfect centration. In addition, square edge IOLs, do not eliminate the most common postoperative complication of cataract surgery which is the PCO. Our data indicate that the ring prevents the formation of PCO acting as a mechanical barrier.