Bausch & Lomb Incorporated
The purpose of this study is to verify the post-market safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO), an expected complication related to IC-8 Apthera IOL implantation.
Prospective, multi-center, single-group, non-randomized new enrollment post approval study to assess the post-market safety of the IC-8 Apthera IOL after Nd:YAG laser capsulotomy following sufficient surgeon training of the sponsor-recommended standardized Nd:YAG laser capsulotomy technique. All subjects will undergo approximately 6 study visits and will be followed 24 months post IC-8 Apthera IOL implantation. There is one study group: subjects previously implanted with the IC-8 Apthera IOL and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG lase…
Inclusion Criteria: * 22 years of age or older, any race and any gender; * Posterior capsule opacification (PCO) requiring treatment in the IC-8 Apthera IOL eye * Able to comprehend and have signed a statement of informed consent; * Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits; * Clear intraocular media in both eyes; * Preoperative corneal astigmatism ≤1.5 D in the IC-8 Apthera IOL eye prior to IC-8 Apthera implantation; * Prior IC-8 Apthera IOL implantation in one eye and a monofocal/monofocal toric IOL in the ot…