Prospective, non-randomised, long term clinical evaluation of a foldable hydrophilic single piece intraocular lens: results of the Centerflex FDA study

Assessment of a single-piece hydrophilic acrylic IOL for piggyback sulcus fixation in pseudophakic cadaver eyes

“…It is manufactured from the same material used in the C-flex IOL (Rayner Intraocular Lenses Ltd.), which was approved for sale by the U.S. Food and Drug Administration for in-the-bag implantation. [18][19][20] One problem reported with initial piggyback implantation of IOLs is the formation of ILO. 8,9 Several methods to prevent ILO, including creation of a relatively large capsulorhexis and implantation of the piggyback IOL in the ciliary sulcus rather than in the capsular bag, have been shown to decrease the incidence of this complication.…”

Evaluation of a new single-piece 4% water content hydrophobic acrylic intraocular lens in the rabbit model

“…This was to address previous observations of the lack of barrier effect against PCO at the level of the optic-haptic junctions of other 1-piece hydrophobic or hydrophilic acrylic designs. [11][12][13] The aim of this study was to assess uveal and capsular biocompatibility of the new 1-piece hydrophobic acrylic IOL in the rabbit model.…”

Influence of 360-degree enhanced optic edge design of a hydrophilic acrylic intraocular lens on posterior capsule opacification

“…The PCO data were then compared to 36 Centerflex IOL images of 36 patients who had participated in a previous FDA study. 1 The C-flex and Centerflex groups were matched in terms of inclusion/exclusion criteria, age distribution, and follow-up time (6 and 12 months).…”

“…However, the sharp optic edge design excludes the optic-haptic junction. 1 Experimental studies of single-piece IOLs show that the lack of a sharp edge at this junction might be a gateway for migrating lens epithelial cells (LECs), thus contributing to higher levels of posterior capsule opacification (PCO). 2,3 According to our Heidelberg PCO database, 4 eyes with Centerflex IOLs have lower PCO values than eyes with IOLs with round optic edges but have higher PCO scores than eyes with hydrophobic IOLs with sharp optic edges.…”

“…1 The refractive index is 1.46 and the water content, 26%. The IOL haptics are extended in a C-like curvature.…”