Abstract
Purpose :
To present safety and efficacy, clinical and surgical observations regarding a novel intracapsular implant
Methods :
Ongoing prospective study of 120 patients with 12 months follow-up. The novel implant (fixOflex, EYE-PCR, Netherlands) is a hydrophilic acrylic ring (9.8mm diameter, 1.7mm thickens) injected through a 2.4mm incision prior to the intraocular lens (IOL) implantation. The optic of the IOL is secured in the ring’s retainers. Patients were recruited following randomization at Alexandria El nour Eye Hospital. All patient received the same type of IOL (Tecnis ZCB00, J&J, NJ ).
Results :
Mean best corrected visual acuity and spherical equivalent was 0.92 ± 0.15 and -0.76 ± 0.86 respectively, 6 months postoperatively.
Mean postoperative anterior chamber depth was 4.26 ± 0.53 mm at six months follow up. Endothelial cell dencity at six months postoperatively was within normal limits (2268±432) after cataract surgery. No anterior chamber reaction or IOP changes were observed. Mean time for ring implantation was 1 min and 9 sec. No serious adverse events were observed. No Posterior Capsule Opacification (PCO) was observed (120 cases 6 months follow-up, 59 patients 1 year follow-up).
Conclusions :
FixOflex provides an open capsule space for fast and safe IOL implantation providing postoperative stabilisation. The ring and IOL positioning is easy to control while additional minor manipulations are rarely needed.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.