Post-Market Clinical Investigation of the Clareon® IOL
Research type
Research Study
Full title
Post-Market Clinical Investigation of the Clareon® IOL
IRAS ID
236521
Contact name
Mayank Nanavaty
Contact email
Sponsor organisation
Alcon Research Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 7 months, 15 days
Research summary
Research Summary
The Clareon IOL (Model SY60WF) is a monofocal intraocular lens intended as a replacement of the human crystalline lens in adult patients following cataract surgery.The rationale to conduct this post-market study is to collect data on the safety and effectiveness of the Clareon IOL after 3 years from the surgery. These data are required to support Market Access requirements including the development of a product value dossier.
The study will be conducted at 10-20 clinical sites worldwide, 2 sites are planned to be activated in the UK (both are NHS sites).
Approximately 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 Clareon and will attend a total of 12 study visits over a period of approximately 36 month: 1 preoperative screening visit (Visit 0); 2 operative visits (Visit 00 and Visit 00A) and 9 post-implantation visits (Visits 1-7A).
Post-implantation visits will occur at the following intervals:
Visit 1 and Visit 1A (Day 1-2 post-implantation, first and second eye),
Visit 2 and 2A (Day 7-14 post-implantation, first and second eye),
Visit 3A (Day 30-45 post-implantation from 2nd eye surgery),
Visit 4A (Day 120-180 post-implantation from 2nd eye surgery),
Visit 5A (Day 330-420 post-implantation from 2nd eye surgery),
Visit 6A (Day 630-780 post-implantation from 2nd eye surgery),
Visit 7A (Day 990-1140 post-implantation from 2nd eye surgery).
Visit day calculations for Visits 1 and 2 are based off of the day of first eye surgery (Visit 00)and calculations for Visits 1A-7A are based off of the day of second eye surgery (Visit 00A).Unscheduled visits may be conducted if needed for medical attention.
Summary of Results
A lay summary was not planned at time of trial initiation.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
18/WM/0017
Date of REC Opinion
12 Feb 2018
REC opinion
Further Information Favourable Opinion