Posterior capsular opacification in hydrophobic and hydrophilic IOLs
Research type
Research Study
Full title
A prospective randomized controlled clinical study to measure posterior capsular opacification, objective measurement of glistenings and intraocular lens tilt and decentration as well as visual outcomes following insertion of a monofocal, aspheric, hydrophobic acrylic intraocular lens: the RayOne® Hydrophobic lens 800C and a monofocal aspheric, hydrophilic acrylic intraocular lens: the RayOne® Hydrophilic lens 600C.
IRAS ID
265864
Contact name
David O'Brart
Contact email
Sponsor organisation
Guy's & St Thomas' Foundation NHS Trust
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Posterior capsular opacification (PCO) is a condition where opacification can develop across the previously clear posterior capsule (skin of the removed cataractous lens) behind the implanted intraocular lens (IOL), months to years after cataract surgery. If they encroach over the visual axis loss of vision will ensue. PCO often causes significant visual morbidity and when symptomatic generally requires surgical intervention typically with a laser capsulotomy. Whilst this is a relatively quick, painless out-patient procedure, it does require patient compliance and has rare sight-threatening complications (lens damage, retinal swelling, retinal detachment). Furthermore, it has significant financial implications with additional costs both in terms of laser purchase and maintenance and extra surgical and clinic time. Therefore, strategies to retard or eliminate PCO occurrence are very important. PCO development depends on several factors, including the IOL design and material.
Glistenings are small, fluid-filled spaces that develop with time within most materials used to make IOLs during cataract surgery. Studies investigating the effect of IOL glistenings on vision have reported conflicting results. It is reasonable to hypothesise, however, that glistenings influence vision since by their very nature they will disrupt 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.
We propose to investigate and compare the occurrence and extent of PCO and glistenings in the Rayner RayOne® Hydrophobic 800C intraocular lens and the RayOne Hydrophillic 600C 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.
REC name
Wales REC 6
REC reference
19/WA/0273
Date of REC Opinion
3 Oct 2019
REC opinion
Further Information Favourable Opinion