Clinical Investigation of the modified monofocal aspheric 600C IOL
Research type
Research Study
Full title
Clinical Investigation of the Modified Rayner Monofocal Aspheric 600C (with axis marks) Intraocular Lens
IRAS ID
174394
Contact name
Graeme Young
Contact email
Sponsor organisation
Rayner Intraocular Lenses Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 0 days
Research summary
This is a prospective, open-label, two year multicentre investigation to evaluate the safety, effectiveness, and rotational stability of a new CE-marked monofocal intraocular lens (called the 600S IOL) in subjects undergoing routine cataract extraction. The 600S Monofocal Aspheric IOL is a modified version of the 600C lens that incorporates axis marks (also CE marked).
An IOL is a Class IIb optical device that is surgically implanted into the capsular bag to replace a cataract. The Rayner 600S IOL is CE-marked (i.e. approved for use in the European Union) but not yet commercially available.
Up to five sites have been invited to participate in this study, two of which are located in the UK. The other three sites are located in Germany, Spain and Portugal. The two UK sites (Birmingham and Midland Eye Centre, City Hospital and Royal Manchester Eye Hospital) will each enrol approximately 25 participants. Collectively, approximately 125 participants are targeted to be enrolled, so that approximately 100 successfully complete the study. Participants will be volunteers invited to take part by the investigators. They will be recruited based on having healthy eyes apart from needing cataract surgery. There will be no randomisation, as all eligible subjects will undergo the same treatment and data will be compared with historical controls.
This study involves the following assessments, some routinely performed before/after cataract surgery including:
• Vision measurement
• Intraocular pressure measurement
• Pupil dilation: using eye drops
• Biomicroscopic assessment of the anterior and posterior ocular tissues
• Biomicroscopic examination of the external eye and surrounding structures
• Ocular biometry measurements
• Evaluations of the IOL
• Patient Questionnaires
Participants will undergo such ophthalmic evaluations at regularly scheduled intervals through 180 days to assess rotational stability and continue to 780 days to determine long-term safety and performance of the IOL.REC name
Wales REC 4
REC reference
15/WA/0122
Date of REC Opinion
19 May 2015
REC opinion
Further Information Favourable Opinion