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Safety and efficacy of a novel intraocular lens

Poster Details

First Author: P.Stodulka CZECH REPUBLIC

Co Author(s):    P. Rozsival              

Abstract Details



Purpose:

To evaluate the safety and effectiveness of a hydrophilic acrylic intraocular lens with a novel design of two circular haptic rings on the anterior and posterior edges of the optic. Animal and in vitro studies performed with this IOL demonstrated significantly less capsular fibrosis in the study eyes than in the control eyes, which were implanted with commercially available FDA-approved intraocular lenses.

Setting:

Gemini Eye Clinics eye clinic of Charles University in Hradec Kralove, Czech Republic

Methods:

A prospective, multicenter, first-in-human clinical study with ethical committee approval. 30 eyes (15 patients) with cataract and no other intraocular pathology. All eyes implanted with a monofocal intraocular lens made of a proprietary 18% hydrophilic UV filtering copolymer of hydroxyethyl methacrylate and methyl methacrylate, with a 5.8 mm optic and contiguous haptic consisting of two haptic rings of 8.8 mm in diameter (Zephyr intraocular lens, Anew IOL Technologies, Inc., Bristol, Tenn., US). The rings are connected by pillars to ensure adequate spacing between the rings in the capsule (2mm), and to which are affixed five haptic bridges that connect the optic to the haptic rings. Follow up 3 months postoperatively to monitor refractive stability and assess the magnitude of refractive change over time. The follow up will continue further on. The primary objective of the multicenter study is to demonstrate safe and reliable implantation of the Zephyr IOL, while secondary endpoints are refractive stability and minimization of capsular fibrosis.

Results:

All implantations were uneventful. No signs of inflammation were noted. The position of the lens and postoperative refraction appears stable during 3 months follow up. No anterior or posterior capsular fibrosis was observed.

Conclusions:

This novel, double-ringed haptic IOL is designed to maintain a separation between the anterior and posterior capsular surfaces in order to facilitate the circulation of aqueous humor around the lens optic. Initial laboratory testing in animal and human cadaver eyes have confirmed post-surgical capsular health and diminished fibrosis of the capsule. The first short term follow up showed promising results. The longer follow up on a larger patient group will be referred in the future. FINANCIAL INTEREST: NONE

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