Patients
adnexal, sight-threatening, uveitis, cataract, trauma, periocular infections, blepharitis, Fuchs’ endothelial dystrophy, immune-compromised, comorbidity, cognitive or behavioural conditions, corneal oedema, corneal astigmatism, Johnson & Johnson Vision, cataract nigrans-posterior polar cataract, staphylomas, NL70320.028.19).Patients, glaucoma, lens luxation
BILATERAL CATARACTS, PSEUDOEXFOLIATION SYNDROME, IOL, IRIDODONESIS, ENDOPHTHALMITIS, UVEITIS, CATARACT, MACULAR OEDEMA, IODINE ALLERGY, BLEPHARITIS, MYOPIA, MACULAR DISEASE, GLAUCOMA, LEUKAEMIA, DIABETES MELLITUS WITH DIABETIC RETINOPATHY, INTRAOCULAR PRESSURE
This study was a prospective, comparative, randomised clinical trial that was conducted in the Elisabeth-TweeSteden Hospital, Tilburg, the Netherlands. A total of 70 patients with an age ranging from 52 to 87 years old and requiring cataract surgery were recruited and included in the study consecutively. All of them were informed about the nature of the study and signed an informed consent prior to their inclusion following the tenets of the Declaration of Helsinki. Furthermore, the study protocol was revised and approved by the ethics committee of the county of Brabant (METC Brabant) (Reference number: NL70320.028.19).Patients were eligible for inclusion in the study if they suffered from bilateral cataract, the surgery in the second eye was planned to be performed within 2 weeks after the first eye, the bilateral cataract surgery was expected to be uncomplicated, and the following conditions were present: corneal astigmatism of less than 1 D, axial length between 21 and 27 mm, and mean corneal power between 41 and 47 D. Regarding exclusion criteria, the following conditions were considered: age < 18 years; insufficient understanding of the Dutch language to comply with study procedures and/or complete patient questionnaires; inability to complete follow-up or comply with study procedures; non-routine cataract surgery (e.g. cataract surgery combined with another ocular procedure); cognitive or behavioural conditions that might interfere with surgery; conditions that increase the risk of endophthalmitis, such as current ocular, adnexal, or periocular infections (e.g. untreated blepharitis); immune-compromised (e.g. systemic corticosteroid use, leukaemia) or iodine allergy; factors that increase the risk of refractive surprise, such as abnormal axial lengths (< 21 mm or > 27 mm) or a difference between both eyes of > 1.5 mm, abnormal keratometry readings, previous refractive surgery, or myopia with posterior staphylomas; conditions that increase the risk of corneal oedema (e.g. Fuchs’ endothelial dystrophy); factors that increase the risk of complicated surgery, such as previous ocular surgery, previous perforating, or blunt eye trauma, eye, adnexal, or anatomical abnormalities (including pseudoexfoliation syndrome); lens luxation or iridodonesis, or cataract nigrans-posterior polar cataract, sight-threatening comorbidity, glaucoma, or intraocular pressure of > 24 mm Hg, uveitis, diabetes mellitus with diabetic retinopathy and macular oedema; and any macular disease.Patients who were willing to participate and met the inclusion and exclusion criteria were randomised to either the implantation of the Vivinex iSert© (Hoya Surgical Optics, Chromos, Singapore) or Tecnis Eyhance ICB00© (Johnson & Johnson Vision, Jacksonville, FL, USA) IOL. Each patient received a randomization number from a computerised random number generator. In case a patient did not want to be randomised, he or she was not included in this study. The follow-up duration per patient was up to 3 months after surgery.