Safety and Effectiveness of Hydrophobic Acrylic Anterior Chamber Phakic IOL in High Myopia: 5-Year Postoperative Results
Narrative Responses:
Purpose
To evaluate safety and effectiveness of the AcrySof Cachet Phakic Lens (PIOL) in patient with high myopia.
Methods
This is an integrated analyses at 5-years of 360 subjects from above studies who were implanted AcrySof Cachet Phakic Lens (L-series). Subjects (≥18 years of age) had stable moderate to high myopia (mean spherical equivalent -10.41± 2.31 diopters (D), and refractions within ±0.5 D at least 12 months before surgery. Clinical outcomes at 5 years included spherical equivalent (SE), predictability of refraction, uncorrected visual acuity (UCVA), and endothelial cell density (ECD).
Results
SE at 5 years was -0.34±0.59 (N=315), and refraction was within ± 0.5 D of target in 67.3% (212/315) of subjects. Average UCVA was 0.05±0.16 logMAR (N=150), with 90.7% (136/150) of subjects showing 20/32 or better. Central ECD averaged 2611.6±346.7 cells/mm2 (N=314) at the 5-years postoperative compared with 2857±286.9 cells/mm2 (N=359) preoperatively. Peripheral ECD averaged 2630.0±398.3 cells/mm2 (N=321) 5 years postoperatively, compared with 2956.8±296.3 cells/mm2 (N=359) preoperatively. Cumulative serious adverse events (reported in 360 subjects) included cataract formation (4.2%), synechia (5.3%), raised IOP requiring treatment (2.8%), IOL replacement (2.5%) and pupil ovalization (0.3%).
Conclusion
This integrated multinational analysis highlights the long term safety and good visual acuity of AcrySof Cachet PIOL. There was accurate predictability of refraction with no detriment to contrast sensitivity. Bi-annual long term monitoring is recommended to monitor possible ECD changes for the life of the lens.