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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: ACRYSOF CACHET Phakic Lens (L-series)

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).

• Study Type: Interventional
• Enrollment (Actual): 657
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr. Project Lead, Surgical, Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2011
• Primary Completion (Actual): June 15, 2018
• Study Completion (Actual): June 15, 2018

Study Registration Dates

• First Submitted: December 20, 2011
• First Submitted That Met QC Criteria: December 20, 2011
• First Posted (Estimate): December 22, 2011

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 25, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Intraocular Lens (IOL); Phakic Lens
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: C-09-043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes