Long Term Safety Protocol for the AcrySof CACHET Phakic Lens

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: ACRYSOF CACHET Phakic Lens (L-series)

• Registration Number: NCT01497067
• Lead Sponsor: Alcon Research

Brief 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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-11-21
• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-22
• Primary Completion: 2018-06-15
• Study Completion: 2018-06-15
• Status Verified: 2019-06
• Results First Submitted: 2019-06-03
• Results First Submitted QC: 2019-06-03
• Last Update Submitted: 2019-06-25
• Results First Posted: 2019-06-26
• Last Update Posted: 2019-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 657

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.

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CACHET	ACRYSOF CACHET Phakic Lens (L-series)	ACRYSOF CACHET Phakic Lens (L-series) previously implanted

Primary Outcome Measures

Name	Time	Method
Central Endothelial Cell Density (All Eyes)	Year 4 to Year 10 postoperative from previous study (C-02-23, C-02-40, C-03-21, and C-05-57)	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.

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States