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Objective: To evaluate safety and refractive efficiency after posterior chamber diffractive implantable phakic contact lens (IPCL) surgery. Material and Methods: A prospective non-randomized case-series study was performed on 54 myopic eyes of 27 patients who had undergone diffractive IPCL surgery. Corneal endothelial cell density (ECD), central corneal thickness (CCT), intra-ocular pressure (IOP), vault, uncorrected distance (UDVA), spherical equivalent (SE) and defocus curve, were all evaluated twelve months after surgery. The presence of cataracts was evaluated by slit-lamp during a postoperative follow-up. Results: Mean age was 47 ± 2.62 years-old. Mean SE decreased, from -5.95 ± 2.56 D in a pre-operative stage, to -0.25 ± 0.25 D twelve months after surgery. Achieved UDVA was 20/20 in 24.1% of all cases, 20/25 in 74.1% of them, and 20/32 in all remaining cases. No eyes suffered lost lines of vision. The binocular defocus curve was 0.06 ± 0.05 logMAR for a -3.0 D of defocus; 0.11 ± 0.04 logMAR for a -1.5 D of defocus, and 0.08 ± 0.03 logMAR for a 0 D of defocus. Twelve months after surgery, mean ECD had decreased by 1.43 %, whereas mean CCT had increased by 0.06 %, without any significant statistical difference (p = 0.28 and p = 0.93 respectively). No difference (p: 0.86) in the vault was observed at 6 months vs.12 months, as well as between IOP measurements (p = 0.22). There were no non-intra or postoperative complications, and, specifically, no cataracts developed either. Conclusions: Diffractive IPCL was implanted safely. Corneal endothelial CD, CCT, vault, and IOP remained stable twelve months after surgery. Visual acuity for distance, intermediate and near sight were achieved without spectacles.

Background : To evaluate safety and refractive efficiency after posterior chamber diffractive implantable phakic contact lens (IPCL) surgery was performed.Methods: A prospective n on-randomized observational case-series study was performed in 54 myopic eyes from 27 patients who underwent diffractive IPCL surgery. The corneal endothelial cell density (ECD), central corneal thickness (CCT), intra-ocular pressure (IOP), vault, uncorrected distance (UDVA), spherical equivalent (SE) and defocus curve, were evaluated 12 months after implantation of the diffractive IPCL. By slit-lap, the presence of cataract was evaluated during post-operative follow-up. Results: Mean age was 47 ±2.62 years-old. The mean SE decreased from -5.95 ±2.56 D pre-operatively to -0.25 ± 0.25 D at 12 months after surgery . The UDVA achieved was 20/20 in 24.1%, 20/25 in 74.1%, remaining eyes obtained 20/32, and no eye lost lines of vision. The binocular defocus curve was 0.06 ±0.05 logMAR for -3.0 D of defocus, 0.11 ±0.04 logMAR for -1.5 D of defocus and 0.08 ±0.03 logMAR for 0 D of defocus. The mean ECD decrease 1.43% and the mean CCT increase 0.06% at 12 months post-operative, without a statistically significant difference ( p : 0.28 and p : 0.93 respectively). No difference ( p : 0.86) in vault was observed at 6 months vs. 12 months, as well as between IOP measurements ( p : 0.22). Non intra or post-operative complications occurred, and specifically cataract did not develop.Conclusions: Diffractive IPCL was implanted safely. Corneal endothelial CD, CCT, vault and IOP remained stable 12 months after surgery. Visual acuity for distance, intermediate and near sight could be improved without spectacles in myopic population with presbyopia.

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