Clinical Study of an Investigational Intraocular Lens
Research type
Research Study
Full title
A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the\nACRYSOF IQ Extended Depth of Focus (EDF) IOL
IRAS ID
220207
Contact name
Ali Mearza
Contact email
Sponsor organisation
Alcon Research Ltd
Duration of Study in the UK
1 years, 3 months, 26 days
Research summary
Alcon Laboratories has developed a new intraocular lens (ACRYSOF® IQ Extended Depth of Focus IOL) to provide a better intermediate vision while maintaining the patients’ far vision after the cataract removal and implantation of a monofocal intraocular lens. The purpose of this study is to demonstrate that the performance and the safety of the new lens are superior compared to available on the market ACRYSOF IQ Monofocal intraocular lens.\nThe study will be conducted at approximately 13 clinical sites worldwide, 4 sites are planned to be activated in the UK. \nApproximately 200 adult men and women diagnosed with cataract in both eyes will take part in the study. They will be implanted with an investigational lens (ACRYSOF® IQ Extended Depth of Focus IOL model number DFT015) or a control lens (ACRYSOF® IQ Monofocal IOL, model number SN60WF) and will return to clinic for 7 post-surgery visits. The involvement will last approximately 8 month for each participant, including before surgery visits, surgery and post-surgery follow-up.\n\n\n
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
17/EE/0026
Date of REC Opinion
2 May 2017
REC opinion
Further Information Favourable Opinion