ABSTRACT
PURPOSE: To evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL; enVista model MX60; Bausch & Lomb, Rochester, NY, USA) when used to correct aphakia following cataract extraction in adults. METHODS: This was a prospective case series (NCT01230060) conducted in private practices in the US. Eligible subjects were adult patients with age-related cataract amenable to treatment with standard phacoemulsification/extracapsular cataract extraction. With follow-up of 6 months, primary safety and effectiveness end points included the rates of US Food and Drug Administration (FDA)-defined cumulative and persistent adverse events and the percentage of subjects who achieved best-corrected visual acuity (BCVA) of 20/40 or better at final visit. To evaluate rotational stability, subjects were randomized (1:1:1:1) to have the lens implanted in one of four axis positions in 45° increments. RESULTS: A total of 122 subjects were enrolled. The rate of cumulative and persistent adverse events did not significantly exceed historical controls, as per FDA draft guidance. At the final postoperative visit, all subjects (100%) achieved a BCVA of 20/40 compared with the FDA historical control of 96.7%. Rotation of the IOL between the two final follow-up visits was ≤5° for 100% of eyes, and refractive stability was demonstrated. A low evaluation of posterior capsule opacification score was demonstrated, and no glistenings of any grade were reported for any subject at any visit. CONCLUSION: This study demonstrated the safety and effectiveness of the MX60 IOL. Favorable clinical outcomes included preserved BCVA, excellent rotational and refractive stability, no glistenings, and a low evaluation of posterior capsule opacification score.
ABSTRACT
We describe a case of pigmentary dispersion syndrome resulting from secondary piggyback implantation of a 3-piece hydrophobic acrylic squared-edged intraocular lens (IOL) in the ciliary sulcus. The intraocular pressure remained elevated despite pharmacological treatment, with a heavily pigmented trabecular meshwork. The piggyback IOL was subsequently explanted and replaced by a silicone IOL with smooth round edges. Examination of the explanted IOL under light and scanning electron microscopy showed clusters of pigment epithelial cells located around the periphery of the anterior optic surface.
Subject(s)
Acrylic Resins , Exfoliation Syndrome/etiology , Lens Implantation, Intraocular/adverse effects , Lenses, Intraocular , Aged , Ciliary Body/surgery , Device Removal , Humans , Intraocular Pressure , Iris/ultrastructure , Male , Microscopy, Electron, Scanning , Pigment Epithelium of Eye/ultrastructure , ReoperationABSTRACT
PURPOSE: To report clinical and spectrographic analyses of 2 explanted hydrophilic acrylic intraocular lenses (IOLs). SETTING: John A. Moran Eye Center, Salt Lake City, Utah, USA, and Johannes Gutenberg-University, Department of Ophthalmology, Mainz, Germany. METHODS: We report 6 cases of opacification of MemoryLens IOLs (Ciba Vision) that occurred approximately 2 years after implantation. The anterior and posterior surfaces of the IOLs had a white, frosted appearance, and the IOLs' interior looked brown, similar to the appearance of a brunescent cataract. Two of the IOLs were explanted because of a significant decrease in visual acuity. The IOLs were sent for further clinicopathologic analysis including scanning electron microscopy and energy dispersive x-ray spectroscopy (EDX). RESULTS: Microscopic analysis revealed multiple, fine, granular deposits of various sizes on the surface of the lens optics. The EDX analysis showed the presence of calcium within the deposits. CONCLUSIONS: Our cases show that hydrophilic acrylic IOLs can opacify even years after implantation. Analysis of the explanted IOLs revealed calcification.
