PanOptix Trifocal IOL (ILH297-P003)
Research type
Research Study
Full title
Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal IOLs
IRAS ID
204636
Contact name
Amir Hamid
Contact email
Sponsor organisation
Alcon Research Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 11 days
Research summary
After a cataract surgery with implanted monofocal lenses many patients require reading glasses to compensate for the loss of the ability to see clear at intermediate or near distances. Multifocal lenses offer an opportunity to correct the near and distance vision. Trifocal lenses improve on multifocal lenses by providing an intermediate vision, which might be an additional benefit to the patients.
This study involves two types of trifocal lenses: a test product - ACRYSOF® IQ PanOptix™ Presbyopia-Correcting IOL Model TFNT00, and a control product - AT LISA tri IOL Model 839MP. Both lenses are CE marked products and will be used within their intended purpose.
The study is designed to demonstrate that the test lenses provide a non-inferior visual performance compared to the control lenses.
The study will be conducted in 7 countries around the world (in Europe, Latin America and Asia).
It is expected that approximately 180 prosepctive participants will be screened, and 160 will be implanted with the study lenses.
To be enrolled in this study the candidates will need to be 22 years of age or older, have no ocular pathology that confound study outcomes, require cataract extraction and desire a lens that provides the potential for near, intermediate and distance vision.
The total expected duration of the study is of 13 months, and expected duration of the study for each participant is of approximately 7 months.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
16/WM/0189
Date of REC Opinion
3 May 2016
REC opinion
Further Information Favourable Opinion