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

Primary Purpose

Presbyopia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

AcuFocus Corneal Inlay ACI 7000 PDT

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring presbyopia

Eligibility Criteria

45 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients prev. impl. with ACI 7000 PDT

Arm Description

AcuFocus Corneal Inlay ACI 7000 PDT

Outcomes

Primary Outcome Measures

Change (Increase) in Uncorrected Near Visual Acuity

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01895088

First Posted

May 3, 2013

Last Updated

July 6, 2017

Sponsor

AcuFocus, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01895088

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AcuFocus, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Presbyopia

Keywords

presbyopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

271 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients prev. impl. with ACI 7000 PDT

Arm Type

Experimental

Arm Description

AcuFocus Corneal Inlay ACI 7000 PDT

Intervention Type

Device

Intervention Name(s)

AcuFocus Corneal Inlay ACI 7000 PDT

Other Intervention Name(s)

AcuFocus KAMRA inlay

Intervention Description

Inlay implanted in cornea for improvement of near vision

Primary Outcome Measure Information:

Title

Change (Increase) in Uncorrected Near Visual Acuity

Description

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

Time Frame

Baseline and 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: