Study design
opacification, pseudophakic, Diabetic Retinopathy
IOL, DIABETIC RETINOPATHY, BEST, POSTERIOR CAPSULE OPACIFICATION, DILATION
This post-market clinical investigation was a prospective, multicentric, randomized, bilateral, comparative, paired-eye, open-label study at 4 study sites in France and Germany with a 3-year postoperative follow-up.The Ethics Committee of the Heidelberg University, Heidelberg, Germany approved the study and informed consent was obtained from all participants. This study was conducted in accordance with Good Clinical Practices, ISO 14155:2011, the Declaration of Helsinki and all other applicable laws and regulations in Germany and France. This study has been registered in the German Clinical Trials Register on 18/08/2017 under the trial registration number DRKS00012768.The primary endpoints were evaluation of glistening and measurement of PCO at 3-years postoperatively.Standardized retroillumination photographs of the pseudophakic anterior segments were obtained following pupil dilation at each postoperative visit. Density areas were identified and marked on the computer screen by a grader. The individual PCO score for each eye was calculated via Evaluation of Posterior Capsule Opacification (EPCO) by multiplying the density of the opacification (graded from 0 to 4) by the fractional PCO area involved behind the IOL optic. The EPCO assessment has been performed by an external independent blinded Reading Center. EPCO calculated the surface density of opacification mathematically by performing pixel counts. The density of the opacification behind the IOL was clinically graded as follows: 0 = none; 1 = minimal; 2 = mild; 3 = moderate; 4 = severe. Additionally, routine slit lamp examinations were done to subjectively assess the degree of posterior capsular bag opacification.At each center, a single investigator assessed the number of glistenings on the slit lamp under pupil dilatation for paired eyes. The observer was masked for the visual testing results and IOL type, and rated glistenings based on the modified severity rating scale as published by Christiansen et alSecondary endpoints included Best Corrected Distance Visual Acuity (BCVA), proportion of subjects achieving a BCVA in Snellen of ≥ 20/40 (0.3 logMAR), and contrast acuity (CA). Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity charts were used in an illuminated light box to determine uncorrected visual acuity, BCVA, and low contrast VA based on the number of letters read at 4.0 m distance under photopic (85 cd/m