Posterior capsule opacification with two similar-design hydrophobic acrylic intraocular lenses: 3-year results of a randomized controlled trial.

PURPOSE: To compare intraindividually the incidence and intensity of posterior capsule opacification (PCO) and Nd:YAG capsulotomy rates between 2 similar open-loop single-piece hydrophobic acrylic intraocular lenses (IOLs) differing slightly in their particular material, optic surface, and sharp posterior edge design over a period of 3 years.

SETTING: Department of Ophthalmology, Medical University Vienna, Vienna, Austria.

DESIGN: Randomized, prospective, patient-masked and examiner-masked clinical trial with intraindividual comparison.

METHODS: 100 patients randomly received a Vivinex XY1 IOL in 1 eye and a Clareon CNA0T0 IOL in the fellow eye. The amount of PCO (score 0 to 10) was assessed subjectively and objectively with digital retroillumination pictures using automated image analysis software (Automated Quantification of After-Cataract). Corrected distance visual acuity and the presence of glistenings, subjective visual symptoms, and Nd:YAG laser capsulotomy rate were noted.

RESULTS: 67 of 100 patients were available for the 3-year follow-up examination. The objective PCO score of the Vivinex XY1 IOLs was 1.0 ± 1.0 compared with the PCO score of 1.5 ± 1.2 for the Clareon CNA0T0 IOLs ( P < .001). 7.5% of patients had a Nd:YAG capsulotomy in the Vivinex XY1 eye, and 9.0% had a capsulotomy in the Clareon CNA0T0 eye ( P = 1.0).

CONCLUSIONS: Both hydrophobic acrylic IOLs showed low PCO and YAG rates with a small but significant favor of the Vivinex XY1 IOL compared with the Clareon CNA0T0 IOL. The interaction of various factors such as hydrophobic material, smooth optic surface, and sharp posterior optic edge is the major key for PCO prevention.

CLINICAL TRIAL NUMBER: NCT04369482.