Under comparable phacoemulsification conditions, both the cohesive and dispersive viscoelastic agents were associated with elevated temperatures that would be preventable by ensuring irrigation and aspiration flow before the onset of phacoemulsification power.

Square scleral corneal, square clear corneal, and rectangular clear corneal incisions were constructed in six cadaver eyes that had no previous intraocular surgery. The 3.2 mm or smaller wounds had sutureless closures. To determine their relative abilities to resist leakage and iris prolapse, eyes were tested at external pressures of up to 525 pounds per square inch (psi) at one of two intraocular pressure (IOP) ranges: 10 to 15 mm Hg or 20 to 25 mm Hg. The square scleral corneal (3.2 mm x 3.2 mm) and square clear corneal wounds (3.2 mm x 3.2 mm, 2.0 mm x 2.0 mm, 1.0 mm x 1.0 mm) withstood external pressure without effect at both IOP ranges, up to the maximum 525 psi. This level of external pressure was far greater than pressures withstood by rectangular clear corneal wounds, especially the wound usually constructed in clinical practice (3.2 mm x 2.0 mm), which leaked and demonstrated iris prolapse at 13 psi at the lower IOP. The square clear corneal wounds that were stable at 525 psi, however, are either clinically impractical (visual axis encroachment from 3.2 mm x 3.2 mm wound) or not technologically feasible until the size of phacoemulsification tips and intraocular lenses can be further reduced. Thus, of the procedures for small incision cataract surgery presently in use, the square scleral corneal incision with 1.5 mm internal corneal lip appears to offer greater stability and safety than the conventional rectangular clear corneal incision (3.2 mm x 2.0 mm).

PurposeTo 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.MethodsThis 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.ResultsA 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.ConclusionThis 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.

No abstract

No abstract