This is a multi-centre prospective study involving five different centres in Europe including 52 patients with cataract. The average age was 68.5±10.5 years, 35 females were bilateral implanted with aspheric diffractive multifocal lens implantation of the Tecnis 1-Piece multifocal intraocular lens (IOL), model ZMB00. This is a one piece acrylic foldable posterior chamber lens with and near add of +4D with a ‘C’ loop haptic, designed to be implanted in the capsular bag following phacoemulsification cataract extraction. The lens is made of ultraviolet absorbing hydrophobic acrylic material and has a 6.0mm optic and overall length of 13.0mm. All patients were assessed with a questionnaire regarding the visual symptoms and the satisfactions and corrections of the visual requirement. This was carried out approximately four to six months after the completion of the surgery, including the uncorrected, best corrected distance and near visual acuity, under photopic and mesopic lighting, reading ability, defocus curve testing and ocular examination for complications. All patients underwent cataract surgery under topical anaesthetic, using extended suture microincision phacoemulsification technique. The intraocular lens was implanted into the capsular bag with an injection system. Postoperatively, topical therapy included a combination of antibiotics and steroidal agents were used. The second eye was performed within six weeks of the initial operation. The residual refractive error was 0.01±0.47 D with 56% of the eyes within ±0.25D and 97% within ±1D. The uncorrected visual acuity was 0.02±0.1 logMAR at distance and 0.15±0.3 logMAR at near. It only reduced to 0.7±0.1 logMAR at distance and 0.21±0.25 logMAR at near in mesopic conditions. The defocus curve showed a near addition between 2.5 and 3.0 D, allowing a reading acuity of 0.08±0.13 logMAR with a range of clear vision of less than 0.3 logMAR of approximately 4.0D. The average reading speed was 121.4±30.8 words per minute. Spectacle independence was 100% for distance and 88% for near, with high levels of satisfaction reported. The overall rating for vision without glasses could be explained by preoperative best-corrected distance acuity, postoperative reading acuity and postoperative uncorrected distance acuity in photopic conditions (p<0.001). Four patients (8%) reported glare at night and two different patients (4%) noted glare symptoms during the day. One patient had cystoid macular oedema in one eye which resolved with steroid treatment within three months and one patient had conjunctival hyperaemia and photophobia caused by dry eyes which resolved with anti-inflammatory drugs. The authors conclude that the ZMB00 1-piece Tecnis multifocal IOL provides a good visual outcome at near and distance with minimal adverse effects.
Clinical evaluation of a multifocal aspheric diffractive intraocular lens
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