IC-8 Apthera IOL New Enrollment Post Approval Study

Status Recruiting

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

Clinical Trial Details

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

View Details

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