Safety outcomes
cataract, haemorrhage, deaths, Corneal edema
CORNEAL EDEMA, IOL, ADVERSE EVENTS, CATARACT, HAEMORRHAGE, SECONDARY, LENS, MACULAR EDEMA, PATHOLOGY, INTRAOCULAR PRESSURE
There were no reports of adverse events leading to lens removal or unanticipated adverse device effects in either group. Two AEs were related to the procedure in the Vivinex™ group. There were 12 ocular AEs (17.9%) in eyes implanted with a HOYA lens, with none being related to the device. For the Alcon eyes, 8 ocular AEs (11.9%) were reported with four being related to the procedure. There were total of 4 deaths in both IOL groups, which were not related to the cataract surgery or IOL implantation. Non-serious macular edema (rated mild and moderate) was reported in 2 subjects implanted with a Vivinex™ IOL (3.0%) and one subject implanted with an AcrySof® IOL (1.5%). Corneal edema of mild severity was reported in one subject with an Alcon IOL (1.5%). Mild elevation of intraocular pressure (IOP) was reported in one subject of each group (1.5%). With respect to serious adverse events, there was one report of a retinal pathology (detachment/hole/tear) in a HOYA subject (1.5%), and a haemorrhage in one subject of each group (1.5%). One secondary surgical intervention was reported in a subject implanted with Vivinex™. There were no reports of any persistent adverse events. No serious adverse device effects related to the IOLs were reported during the study.