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NCT01497067 · ClinicalTrials.gov registry record · NA

Long Term Safety Protocol for the AcrySof CACHET Phakic Lens

A NA study, sponsored by Alcon Research.

Completed
Registry status
NA
Development phase
657
Enrollment target

NCT01497067: Completed NA study, sponsored by Alcon Research.

NCT01497067 is a NA study that has completed, run by Alcon Research. The registered enrollment target is 657 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01497067, a NA study, has completed, sponsored by Alcon Research.

COMPLETED
Registry status
NA
Development phase
657 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DEVICE ACRYSOF CACHET Phakic Lens (L-series)

Trial Details

FieldValue
Enrollment Target 657 participants
Start Date 2011-11-21
Est. Completion 2018-06-15
Phase NA
Alcon Research

275 total trials

What the finished NCT01497067 record still lists

NCT01497067 is an interventional study that assigns participants to a tested intervention. The registered 657 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 1 intervention - of which ACRYSOF CACHET Phakic Lens (L-series) is the first listed.

NCT01497067 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01497067 about?

NCT01497067 is a clinical study titled "Long Term Safety Protocol for the AcrySof CACHET Phakic Lens". 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, ...

What is the current status of trial NCT01497067?

This trial is currently completed. It is a NA study. The enrollment target is 657 participants. The study started on 2011-11-21. Estimated completion is 2018-06-15.

What interventions are being tested in trial NCT01497067?

The interventions under investigation include: ACRYSOF CACHET Phakic Lens (L-series) (DEVICE).

Who is sponsoring clinical trial NCT01497067?

This trial is sponsored by Alcon Research, which has 275 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01497067's enrollment target sits among peer trials

657 156th of 2000 higher than 1,845 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01497067, the US trial registry maintained by the National Library of Medicine. NCT01497067 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.