Staar Surgical TICL
This article was originally published in The Gray Sheet
Executive Summary
Receipt of CE mark for toric implantable contact lens EU sales makes Staar's TICL the first posterior phakic intraocular lens able to reduce pre-existing astigmatism alongside myopia or hyperopia correction, the company says Dec. 3. The Monrovia, Calif. firm gained conditional IDE clearance in January for a 125-patient U.S. trial investigating the TICL to treat myopia of -3.0 to 20 diopters - and astigmatism of 1.0 to 4.0 D (1"The Gray Sheet" Jan. 14, 2002, In Brief). Staar implanted the first device in a U.S. patient's eye in August, with "excellent results [and] no surprises"...
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Staar Surgical TICL
Toric implantable contact lens gains conditional investigational device exemption clearance for a 125-patient U.S. trial to treat myopia of -3.0 to -20 diopters and astigmatism of 1.0 to 4.0 diopters. The device "is the only phakic intraocular lens" for pre-existing astigmatism and myopia, Staar says. An ongoing U.S. study of a non-toric myopia version, including 529 enrolled cases, shows a 2.3% incidence of lens opacities, with eight of the 12 opacities being "non progressive and showing no loss of best-corrected visual acuity," Staar notes...
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