Long Term Safety Protocol for the AcrySof CACHET Phakic Lens

Alcon

Status: Completed

Conditions: Myopia

Treatments: Device: ACRYSOF CACHET Phakic Lens (L-series)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01497067

C-09-043

Details and patient eligibility

About

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.

Full 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).

Enrollment: 657 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously implanted with an ACRYSOF CACHET Phakic Lens (L-Series) from clinical studies C-02-23, C-02-40, C-03-21 and C-05-57 and eligible for continued follow-up (i.e., exited from the previous study).
• Able to understand and sign a statement of informed consent.
• Willing and able to complete the yearly postoperative study visits.

Exclusion criteria

• None

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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657 participants in 1 patient group

CACHET

Experimental group

Description:

ACRYSOF CACHET Phakic Lens (L-series) previously implanted

Treatment:

Device: ACRYSOF CACHET Phakic Lens (L-series)