Long Term Safety Protocol for the AcrySof CACHET Phakic Lens

Study Overview
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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.

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).

Official Title
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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

Conditions
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Myopia

Intervention / Treatment
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* Device: ACRYSOF CACHET Phakic Lens (L-series)


Participation Criteria
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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. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CACHET<br>ACRYSOF CACHET Phakic Lens (L-series) previously implanted | Device: ACRYSOF CACHET Phakic Lens (L-series)<br>* Intraocular lens for the treatment of moderate to high myopia<br>* Other names: AcrySof Angle-Supported Phakic Lens;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Endothelial Cell Density (All Eyes) | A microscope was used to photograph corneal endothelial cells (cells on the back of the cornea). Three images at the center of the cornea were obtained and sent to a central reading center for analysis. All recorded data from images were used in the analysis. A higher value for density represents a healthier cornea. | Year 4 to Year 10 postoperative from previous study (C-02-23, C-02-40, C-03-21, and C-05-57) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phakic Lens, Intraocular Lens (IOL)