NCT01497067

Long Term Safety Protocol for the AcrySof CACHET Phakic Lens

Long Term Safety Follow-up for Subjects Previously Implanted With the ACRYSOF® CACHET® Phakic Lens in Clinical Studies C-02-23, C-02-40, C-03-21 and C-05-57

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 657 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this long term safety study is to estimate the annualized endothelial cell loss (ECL) rate (for up to 10 years following date of implantation) of subjects previously implanted with the ACRYSOF CACHET Phakic Intraocular Lens (L-series) from precursor clinical studies C-02-23, C-02-40, C-03-21 and C-05-57.

Detailed description

Subjects previously enrolled in protocols C-02-23 (NCT00726024), C-02-40 (NCT00727805), C-03-21 (NCT00726297), and C-05-57 (NCT00727688) who received an L-series lens either in the first eye or second eye (including those who were explanted) were enrolled in this open-label, non-randomized, non-controlled, extension study in which they attended postoperative visits for up to 10 years following the date of implantation. Subjects could enroll in the study at any time, thus the Entrance Visit may have coincided with any visit (Year 4 to Year 10).

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	ACRYSOF CACHET Phakic Lens (L-series)	Intraocular lens for the treatment of moderate to high myopia

Timeline

• Start date: 2011-11-21
• Primary completion: 2018-06-15
• Completion: 2018-06-15
• First posted: 2011-12-22
• Last updated: 2019-07-02
• Results posted: 2019-06-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study