EROV-108-COMP
Research type
Research Study
Full title
Post-market clinical follow-up investigation of the marketed Extended Range of Vision IOL
IRAS ID
151855
Contact name
Vincenzo Maurino
Contact email
Sponsor organisation
Abbott Medical Optics Inc.
Research summary
Presbyopia, defined as the age-dependent loss of accommodative amplitude, affects essentially all human beings beyond the age of 45 and impacts the ability of the eye to focus at near distances. Current surgical options for cataract patients who desire improved vision across a range of distances include a choice of monovision or multifocality. Patients implanted with standard monofocal lenses often need spectacles for reading or performing other near tasks, even if a monovision option is selected. Patients implanted with multifocal lenses, while being able to read and perform other near tasks without spectacles, sometimes experience dysphotopsia (e.g., halos), particularly at night, and have limited intermediate ability (e.g., may need spectacles to work on a computer). Some accommodating lenses are also available on the market, although their effect depends upon fit within the capsular bag or capsular bag elasticity.
AMO has developed a new IOL series designed to bridge the gap between monofocal and multifocal lens performance. The AMO-ERV Model ZXR00 IOL was designed in response to a patient need for lenses that can provide good distance vision, improved intermediate and near vision compared to standard monofocal IOLs, and less dysphotopsia compared to a multifocal IOL. The study devices utilize diffractive technology to extend the range of focus while keeping halos to a minimum. The optical design of the ZXR00 IOL is based on the diffractive technology of the multifocal parent, the AMO TECNIS Multifocal 3-Piece IOL, Model ZM900, with minor modifications to harness the strengths and diminish the weaknesses of standard monofocal and multifocal IOLs.REC name
London - Brent Research Ethics Committee
REC reference
14/LO/0490
Date of REC Opinion
14 Apr 2014
REC opinion
Further Information Favourable Opinion