Investigation of ACRYSOF® IQ PanOptix™ Presbyopia Correcting IOL
Research type
Research Study
Full title
Investigation of ACRYSOF® IQ PanOptix™ Presbyopia Correcting IOL Model TFNT00
IRAS ID
193146
Contact name
Tonya Scoggins
Contact email
Sponsor organisation
Alcon Research Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 15 days
Research summary
This is a prospective, single arm, unmasked, non-randomized, multicenter study of a CE marked medical device - AcrySof® IQ Presbyopia Correcting PanOptix™ Intraocular lens (study lens).
The purpose of this research is to collect data that will provide information on the visual outcomes (results) and assess safety at 1 year (330-420 days) following implantation of the study lens in both eyes.
Approximately 156 adult subjects will be enrolled at approximately 14 sites in Europe and South America.
To participate in this trial, subjects must be 22 years of age or older, with no ocular pathology that confound study outcomes, who require cataract extraction and desire an intraocular lense that provides the potential for near, intermediate and distance vision.
Subjects will be considered enrolled upon consent.
Their involvement will last approximately 1 year. Aside from the two surgery visits, the participants will be asked to return to the clinic for follow-up visits 7 times.
Only one site has been selected in the UK to take part in this study.REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/2089
Date of REC Opinion
7 Mar 2016
REC opinion
Further Information Favourable Opinion