ILT142-P001 v1.0
Research type
Research Study
Full title
Clinical Investigation of Patient Outcomes after IOL Implantation with Different IOL Delivery Systems
IRAS ID
276801
Contact name
Mayank Nanavaty
Contact email
Sponsor organisation
Alcon Research LLC
Clinicaltrials.gov Identifier
DRKS00020134, German Clinical Trials Register (DRKS)
Duration of Study in the UK
0 years, 4 months, 6 days
Research summary
The purpose of this study is to assess the short-term (1-Month) postoperative visual outcomes of patients implanted with different commercially-available monofocal IOLs. In addition, the study will assess corneal morphology observations (changes to the outermost layer of the eye) after IOL implantation with the different IOL implanting devices.
The results from this study may be used to inform additional investigations that will help to differentiate IOL implantation devices from their interaction with the corneal tissue (the transparent front part of the eye). The results from this study may be presented at peer-reviewed conferences or journals.
The study will be conducted at 2 sites only - 1 NHS site in the UK and 1 site in Germany.
Approximately 28 subjects will be randomised in a 1:1:1:1 ratio to receive either Clareon AutonoMe (test product) or one of the three control products (Vivinex iSert, TECNIS iTec and Monarch III D).
Subjects will attend 4 study visits over a period of approximately 108 days.
Visit 0 - Screening visit (-45 days to 0 days prior to Visit 00)
Visit 00 - 1st eye surgery
Visit 000 - 1st eye review (performed within 2.5 hours of Visit 00)
Visit 00A - 2nd eye surgery (0-28 days post Visit 00)
Visit 000A - 2nd eye review (performed within 2.5 hours of Visit 00A)
Visit 1 - follow up visit (both eyes) (21-35 days post Visit 00A)Unscheduled visits may be conducted if needed for medical attention.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
20/WM/0004
Date of REC Opinion
24 Feb 2020
REC opinion
Further Information Favourable Opinion