[Highly refractive silicone lens with sharp optic edge (CeeOn Edge, Model 911): one year results of a multicenter clinical trial on performance and efficacy].

PURPOSE: To investigate the performance and efficacy of a new high refractive index (1.46) silicone intraocular lens with sharp optic edges.

MATERIALS AND

METHODS

In this open prospective multicenter study 149 patients underwent cataract surgery and implantation of CeeOn Edge in one eye. Best corrected visual acuity was determined at day 1 - 2, week 1 - 2, month 6 and month 12 postoperatively. Posterior capsule was clinically evaluated according to existence or absence of posterior capsule opacification (PCO). PCO was defined as relevant if the visual acuity loss exceeded at least two lines. The intraoperative handling of the lens was assessed concerning foldability, haptic handling, positioning, unfolding and general assessment.

RESULTS

Visual acuity increased from preoperatively 0.3 to 0.9 after one year. PCO with impact on visual acuity (loss of 2 lines or more) was recorded in only two patients, after 2 weeks (YAG) resp. 1 year (no YAG). The handling and implantation was considered to be good to very good. No lens-related complications were seen during the one year study period.

CONCLUSIONS

CeeOn Edge, Model 911, restores visual acuity after cataract surgery and shows promising handling results. The low rate of PCO and YAG is most probably related to the sharp edge of the lens.