Long Term Safety Protocol for the AcrySof CACHET Phakic Lens

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

657 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-21

Study Completion Date

2018-06-15

Brief Summary

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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.

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Detailed Description

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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

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Myopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CACHET

ACRYSOF CACHET Phakic Lens (L-series) previously implanted

Group Type EXPERIMENTAL

ACRYSOF CACHET Phakic Lens (L-series)

Intervention Type DEVICE

Intraocular lens for the treatment of moderate to high myopia

Interventions

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ACRYSOF CACHET Phakic Lens (L-series)

Intraocular lens for the treatment of moderate to high myopia

Intervention Type DEVICE

Other Intervention Names

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AcrySof Angle-Supported Phakic Lens

Eligibility Criteria

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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.