RCT comparing Alcon CLAREON with Abbott Medical Optics PCB00 IOLs
Research type
Research Study
Full title
A randomised, controlled study to compare visual performance, refractive outcome, forward light scatter, patient satisfaction and objective measurement of glistenings following insertion of two monofocal, aspheric, hydrophobic acrylic intraocular lenses: the Alcon CLAREON® and the Abbott Medical Optics PCB00 lenses
IRAS ID
232017
Contact name
David O'Brart
Contact email
Sponsor organisation
Guy's and St Thomas' Foundation NHS Trust
Duration of Study in the UK
1 years, 10 months, days
Research summary
Glistenings are small, fluid-filled spaces that develop with time within most materials used to make lenses for implantation in eyes (intraocular lenses) during cataract surgery. They typically develop within weeks to many months following implantation. Their number and size vary. Studies that have been conducted to investigate the effect of glistenings on vision, have reported varying results with some documenting little/no effects and others measurable changes. The conflicting results in such studies are probably due to the measurement methods of vision being insufficiently sensitive. It is reasonable to hypothesise, however, that glistenings have an effect on vision, however small, since by their very nature they will disrupt (reflect, refract) the passage of light when forming an image on the retina. It is for this reason that the manufacturers of intraocular lenses strive to produce materials that will not develop glistenings or other imperfections that may impair lens transparency with time after implantation. The new Alcon CLAREON® intraocular lens has been developed to reduce/eliminate the occurrence of glistenings in AcrySof IOLs. It is made of a new acrylic, hydrophobic polymer, which in the laboratory and early clinical testing has been shown to produce less glistenings than AcrySof and other acrylic hydrophobic materials. It has similar optical properties and dimensions as the Abbot Medical Optics Pcb00 intraocular lens, which is also made of an acrylic polymer and has been implanted into over one million eyes over the past decade, both in the UK and internationally, with no safety concerns.We propose to investigate and compare the occurrence of glistenings in the Abbot Medical Optics Pcb00 intraocular lens (the control) and the new Alcon CLAREON® intraocular lens, in a randomized, controlled clinical study, with each type of lens being put into both eyes of each individual patient on a random basis, with a 12 month follow-up.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
17/WM/0414
Date of REC Opinion
10 Nov 2017
REC opinion
Favourable Opinion