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Clinical Trial Summary

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.


Clinical Trial Description

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 laser capsulotomy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06060041
Study type Observational
Source AcuFocus, Inc.
Contact Danni Fisher
Phone 716-329-1162
Email danni.fisher@bausch.com
Status Recruiting
Phase
Start date September 8, 2023
Completion date September 30, 2027

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