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Long Term Safety Protocol for the AcrySof CACHET Phakic Lens

NCT01497067 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 657

Last updated 2019-07-02

Study results available
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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.

Conditions

  • Myopia

Interventions

DEVICE

ACRYSOF CACHET Phakic Lens (L-series)

Intraocular lens for the treatment of moderate to high myopia

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Sr. Project Lead, Surgical · Alcon Research

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-21
Primary Completion
2018-06-15
Completion
2018-06-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01497067 on ClinicalTrials.gov