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Completed

NCT Number: NCT01895088

A Continuation Study To Monitor The Long Term Safety Of Patients Completing Protocols ACU-P08-020/020A

This is a 2 year follow up study to monitor the long term safety of the ACI 7000PDT in subjects who are still implanted with the ACI and have successfully completed the ACU-P08-020/020A studies.

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McDonald Eye Associates, Fayetteville, Arkansas, United States

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About this study

This is a two year follow up study designed to monitor and obtain long-term safety data of the ACI 7000PDT in subjects who participated and successfully completed the ACU-P08-020/020A studies. Subjects must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form prior to participating. This continuation study follows subjects still implanted with the ACI and includes two visits, at 12-month intervals, after subjects have been exited (at Month 36) from the ACU-P08-020/020A studies. The first visit is at Month 48 following implantation followed by a final Month 60 visit. The study parameters being measured at these two visits include:

  • Specular microscopy
  • Slit lamp and fundus examination (ocular health)
  • Corrected and uncorrected visual acuity
  • Manifest mid-point refraction
  • Corneal topography
  • Dry eye assessment
  • Mesopic and Photopic contrast sensitivity
  • Adverse events and complications

All sites participating in the ACU-P08-020/020A studies were invited to participate in the continuation study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must have completed participation in the ACU-P08-020/020A clinical trial.
  • Patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form.

Exclusion criteria

  • Patients who did not complete ACU-P08-020/020A.

Treatment and study plan

AcuFocus Corneal Inlay ACI 7000 PDT

Device

Inlay implanted in cornea for improvement of near vision

Other names: AcuFocus KAMRA inlay

Primary outcomes

  1. Change (Increase) in Uncorrected Near Visual Acuity

    Time frame: Baseline and 2 years

    The change in the number of lines of threshold visual acuity achieved postoperatively.

Sponsors and collaborators

Lead sponsor

AcuFocus, Inc.

Industry

Registry information

Official study title

A Continuation Study To Monitor The Long Term Safety Of The AcuFocus ™ ACI 7000PDT Patients Completing Protocols ACU-P08-020/020A

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2013
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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